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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / November 2025 / K252964

510(k) cleared

PRIMED Surgical and Procedure Masks

Primed Medical Products, Inc. · Nov 4, 2025 · K252964

FDA cleared the PRIMED Surgical and Procedure Masks from Primed Medical Products, Inc. on Nov 4, 2025 under K252964, a traditional 510(k). The device falls under product code FXX, Mask, Surgical, regulated at 21 CFR 878.4040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 17, 2025. The decision came 48 days later, inside the 90 FDA-day goal for a 510(k).

Primed Medical Products, Inc. has 2 other decisions in the tracker over the last 12 months: K262007 (PRIMED AAMI Level 3 Open Back Gowns), K261811 (PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3)).

Questions & Answers

What did FDA clear under K252964?

K252964 is the FDA 510(k) for PRIMED Surgical and Procedure Masks, submitted by Primed Medical Products, Inc.. FDA's decision date was Nov 4, 2025, under product code FXX (Mask, Surgical).

Who makes the PRIMED Surgical and Procedure Masks?

Primed Medical Products, Inc., based in Edmonton, is the applicant of record for K252964.

How long did the K252964 review take?

FDA received the submission on Sep 17, 2025 and issued its decision on Nov 4, 2025, 48 days later.

← All decisions in November 2025

Sources