510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K921178Substantially Equivalent

Pti-a, Pti-P, Pti-N Disposable Pneumotachs

Medical Associated Services, Inc., Hatfield PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921178 is the FDA 510(k) clearance record for PTI-A, PTI-P, PTI-N DISPOSABLE PNEUMOTACHS, a class II device, cleared for Medical Associated Services, Inc. on under FDA product code JAX (Pneumotachometer). FDA records list 6 510(k) clearances for Medical Associated Services, Inc., from to . As of , FDA records show no recalls naming K921178.

Clearance record

Decision date
Received
(170 days to decision)
Product code
JAX Pneumotachometer
Regulation
21 CFR 868.2550
Device class
Class II
Review panel
Anesthesiology
Applicant
Medical Associated Services, Inc. P.O. Box 530, Hatfield PA
510(k) summary
Statement
Third party review
No

Clearances, product code JAX

Trailing 12 months

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

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