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
K944988Substantially Equivalent

Custom Medical Suspension Strap

Custom Medical Specialties, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944988 is the FDA 510(k) clearance record for CUSTOM MEDICAL SUSPENSION STRAP, a class I device, cleared for Custom Medical Specialties, Inc. on under FDA product code JAY (Support, Breathing Tube). FDA records list one 510(k) clearance for Custom Medical Specialties, Inc. As of , FDA records show no recalls naming K944988.

Clearance record

Decision date
Received
(107 days to decision)
Product code
JAY Support, Breathing Tube
Regulation
21 CFR 868.5280
Device class
Class I
Review panel
Anesthesiology
Applicant
Custom Medical Specialties, Inc. 1445-P Brookville Way, Indianapolis IN
510(k) summary
Statement
Third party review
No

Clearances, product code JAY

Trailing 12 months

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

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