510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K833831Substantially Equivalent

3-Day Bioindicator Release for Steril

Shiley, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833831 is the FDA 510(k) clearance record for 3-DAY BIOINDICATOR RELEASE FOR STERIL, a class II device, cleared for Shiley, Inc. on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 174 510(k) clearances for Shiley, Inc., from to . As of , FDA records show no recalls naming K833831.

Clearance record

Decision date
Received
(135 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Shiley, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code BTR

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