510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943017Substantially Equivalent

Neonatal Restraint and Comfort Systems

K.Bowmed, Inc., North Wilkesboro NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943017 is the FDA 510(k) clearance record for NEONATAL RESTRAINT AND COMFORT SYSTEMS, a class I device, cleared for K.Bowmed, Inc. on under FDA product code FRP (Holder, Infant Position). FDA records list one 510(k) clearance for K.Bowmed, Inc. As of , FDA records show no recalls naming K943017.

Clearance record

Decision date
Received
(209 days to decision)
Product code
FRP Holder, Infant Position
Regulation
21 CFR 880.5680
Device class
Class I
Review panel
General Hospital
Applicant
K.Bowmed, Inc. P.O. Box 216, North Wilkesboro NC
510(k) summary
Summary
Third party review
No

Clearances, product code FRP

Trailing 12 months

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

FDA records show no clearances under product code FRP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FRP, 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