510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
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K071527Substantially Equivalent

Pneupac Vr1 Air Mix

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

K071527 is the FDA 510(k) clearance record for PNEUPAC VR1 AIR MIX, 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 no recalls naming K071527.

Clearance record

Decision date
Received
(122 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. N7w22025 Johnson Dr., 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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BTL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260