510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021841Substantially Equivalent

Comppac Ventilator Models 200 & Ps11 Power Supply/charger

Pneupac, Ltd., Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021841 is the FDA 510(k) clearance record for COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER, a class II device, cleared for Pneupac , Ltd. on under FDA product code BTL (Ventilator, Emergency, Powered (Resuscitator)). FDA records list 20 510(k) clearances for Pneupac , Ltd., from to . As of , FDA records show no recalls naming K021841.

Clearance record

Decision date
Received
(407 days to decision)
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Regulation
21 CFR 868.5925
Device class
Class II
Review panel
Anesthesiology
Applicant
Pneupac , Ltd. Smiths Medical, Waukesha WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTL

Trailing 12 months

FDA records hold no clearances under product code BTL in the trailing twelve months.

FDA records show no clearances under product code BTL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BTL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260