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
K123957Substantially Equivalent

Pneupac Parapac Plus

Abbott Medical, Luton, Bedfordshire, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123957 is the FDA 510(k) clearance record for PNEUPAC PARAPAC PLUS, a class II device, cleared for Smiths Medical International , Ltd. on under FDA product code BTL (Ventilator, Emergency, Powered (Resuscitator)). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show 7 recalls naming K123957.

Clearance record

Decision date
Received
(269 days to decision)
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Regulation
21 CFR 868.5925
Device class
Class II
Review panel
Anesthesiology
Applicant
Smiths Medical International , Ltd. Bramingham Business Park, Luton, Bedfordshire, GB
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