510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955657Substantially Equivalent

North State Plastics Respiratory Mouthpiece

North State Plastics, Inc., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955657 is the FDA 510(k) clearance record for NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE, a class I device, cleared for North State Plastics, Inc. on under FDA product code BYP (Mouthpiece, Breathing). FDA records list 2 510(k) clearances for North State Plastics, Inc., from to . As of , FDA records show no recalls naming K955657.

Clearance record

Decision date
Received
(91 days to decision)
Product code
BYP Mouthpiece, Breathing
Regulation
21 CFR 868.5620
Device class
Class I
Review panel
Anesthesiology
Applicant
North State Plastics, Inc. 12850 E. 40th Ave., Suite 98, Denver CO
510(k) summary
Summary
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