510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K131901Substantially Equivalent

Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2

3B Medical Inc, Lake Wales FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131901 is the FDA 510(k) clearance record for IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2, a class II device, cleared for 3B Medical, Inc. on under FDA product code BZD (Ventilator, Non-Continuous (Respirator)). FDA records list 10 510(k) clearances for 3B Medical, Inc., from to . As of , FDA records show no recalls naming K131901.

Clearance record

Decision date
Received
(181 days to decision)
Product code
BZD Ventilator, Non-Continuous (Respirator)
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
3B Medical, Inc. 21301 Hwy. 27 N., Lake Wales 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