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
SUBSCRIBE / SIGN IN
K012842Substantially Equivalent

V*care Manual Resuscitator

Salter Labs, Mocksville NC / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K012842 is the FDA 510(k) clearance record for V*CARE MANUAL RESUSCITATOR, a class II device, cleared for Ventlab Corp. on under FDA product code BTM (Ventilator, Emergency, Manual (Resuscitator)). FDA records list 74 510(k) clearances for Salter Labs, from to . As of , FDA records show 21 recalls naming K012842.

Clearance record

Decision date
Received
(26 days to decision)
Product code
BTM Ventilator, Emergency, Manual (Resuscitator)
Regulation
21 CFR 868.5915
Device class
Class II
Review panel
Anesthesiology
Applicant
Ventlab Corp. 2934 Hwy. 601 N., Mocksville NC
510(k) summary
Statement
Third party review
No

Clearances, product code BTM

Trailing 12 months
1 clearance under product code BTM in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTM, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260