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The Tracker / October 2026 / K260180

510(k) cleared

Carecube Negative Pressure Isolation Chamber (1BY)

Carecubes, Inc. · Oct 16, 2026 · K260180

FDA cleared the Carecube Negative Pressure Isolation Chamber (1BY) from Carecubes, Inc. on Oct 16, 2026 under K260180, a traditional 510(k). The device falls under product code LGM, Chamber, Patient Isolation, regulated at 21 CFR 880.5450 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jan 21, 2026. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Carecubes, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260180?

K260180 is the FDA 510(k) for Carecube Negative Pressure Isolation Chamber (1BY), submitted by Carecubes, Inc.. FDA's decision date was Oct 16, 2026, under product code LGM (Chamber, Patient Isolation).

Who makes the Carecube Negative Pressure Isolation Chamber (1BY)?

Carecubes, Inc., based in San Francisco, CA, is the applicant of record for K260180.

How long did the K260180 review take?

FDA received the submission on Jan 21, 2026 and issued its decision on Oct 16, 2026, 268 days later.

← All decisions in October 2026