510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K080516Substantially Equivalent

Lamin Air

Remgenic, LLC, Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080516 is the FDA 510(k) clearance record for LAMIN AIR, a class II device, cleared for Remgenic, LLC on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list one 510(k) clearance for Remgenic, LLC. As of , FDA records show no recalls naming K080516.

Clearance record

Decision date
Received
(119 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Remgenic, LLC 24301 Woodsage Dr., Bonita Springs FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZD

Trailing 12 months
11 clearances under product code BZD in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZD, trailing twelve months
MonthClearances
November 20250
December 20252
January 20262
February 20260
March 20260
April 20262
May 20262
June 20261
July 20261
August 20260
September 20261
October 20260