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FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first FDA makes the Draeger VentStar Resus Neo hose removal a Class I recall Control Bionics wins a Class I CE mark for the NeuroStrip muscle sensor Medicare starts paying for Carlsmed Aprevo lumbar fusion under three new codes ABK Biomedical breaks ground on a Missouri plant for its Y90 microspheres Boston Scientific releases the last $8M from Elutia's BioEnvelope sale BlueWind gets a Category I CPT code for subfascial tibial neuromodulation Emboline runs its first US commercial Emboliner cases at Columbia SedMed raises $4M for a toilet lift that runs without power CDRH plans 11 final guidances in FY2027 and puts AI lifecycle management first

The Tracker / September 2026 / K262108

510(k) cleared

FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant (Plain);FAMA Male Latex Condoms Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms Aqueous Lubricant (Dotted);FAMA Male Latex Condoms Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms Aqueous Lubricant (Plain);MO Male Latex Condoms Aqueous Lubricant (Ribbed);MO Male Latex Condoms Aqueous Lubricant (Dotted);MO

Shanghai Personage Hygiene Products Co., Ltd. · Sep 21, 2026 · K262108

FDA cleared the FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant (Plain);FAMA Male Latex Condoms Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms Aqueous Lubricant (Dotted);FAMA Male Latex Condoms Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms Aqueous Lubricant (Plain);MO Male Latex Condoms Aqueous Lubricant (Ribbed);MO Male Latex Condoms Aqueous Lubricant (Dotted);MO from Shanghai Personage Hygiene Products Co., Ltd. on Sep 21, 2026 under K262108, a traditional 510(k). The device falls under product code HIS, Condom, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jun 23, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shanghai Personage Hygiene Products Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262108?

K262108 is the FDA 510(k) for FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant (Plain);FAMA Male Latex Condoms Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms Aqueous Lubricant (Dotted);FAMA Male Latex Condoms Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms Aqueous Lubricant (Plain);MO Male Latex Condoms Aqueous Lubricant (Ribbed);MO Male Latex Condoms Aqueous Lubricant (Dotted);MO, submitted by Shanghai Personage Hygiene Products Co., Ltd.. FDA's decision date was Sep 21, 2026, under product code HIS (Condom).

Who makes the FAMA Male Latex Condoms Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms Aqueous Lubricant (Plain);FAMA Male Latex Condoms Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms Aqueous Lubricant (Dotted);FAMA Male Latex Condoms Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condoms Aqueous Lubricant (Ultra-thin);MO Male Latex Condoms Aqueous Lubricant (Plain);MO Male Latex Condoms Aqueous Lubricant (Ribbed);MO Male Latex Condoms Aqueous Lubricant (Dotted);MO?

Shanghai Personage Hygiene Products Co., Ltd., based in Shanghai, is the applicant of record for K262108.

How long did the K262108 review take?

FDA received the submission on Jun 23, 2026 and issued its decision on Sep 21, 2026, 90 days later.

← All decisions in September 2026