510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970158Substantially Equivalent

Babypac

Pneupac, Ltd., Wake Forest NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970158 is the FDA 510(k) clearance record for BABYPAC, a class II device, cleared for Pneupac, Inc. on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 20 510(k) clearances for Pneupac, Inc., from to . As of , FDA records show no recalls naming K970158.

Clearance record

Decision date
Received
(467 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Pneupac, Inc. P.O. Box 973, Wake Forest NC
510(k) summary
Statement
Third party review
No

Clearances, product code CBK

Trailing 12 months
4 clearances under product code CBK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260