510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K803069Substantially Equivalent

Shell Kraton Thermo-Plastic Rubber Comp.

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

K803069 is the FDA 510(k) clearance record for SHELL KRATON THERMO-PLASTIC RUBBER COMP., a class I device, cleared for Warren E. Collins, Inc. on under FDA product code BYP (Mouthpiece, Breathing). FDA records list 14 510(k) clearances for Warren E. Collins, Inc., from to . As of , FDA records show no recalls naming K803069.

Clearance record

Decision date
Received
(17 days to decision)
Product code
BYP Mouthpiece, Breathing
Regulation
21 CFR 868.5620
Device class
Class I
Review panel
Anesthesiology
Applicant
Warren E. Collins, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code BYP

Trailing 12 months

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

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