510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970448Substantially Equivalent

Pcm 2000; Isolair Apr Model 2735

Tecnol Medical Products, Inc., Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970448 is the FDA 510(k) clearance record for PCM 2000; ISOLAIR APR MODEL 2735, a class II device, cleared for Tecnol Medical Products, Inc. on under FDA product code MSH (Respirator, Surgical). FDA's definition for product code MSH reads: "A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific...". FDA records list 21 510(k) clearances for Tecnol Medical Products, Inc., from to . As of , FDA records show no recalls naming K970448.

Clearance record

Decision date
Received
(83 days to decision)
Product code
MSH Respirator, Surgical
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Tecnol Medical Products, Inc. 7201 Industrial Park Blvd., Fort Worth TX
510(k) summary
Summary
Third party review
No

Clearances, product code MSH

Trailing 12 months

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

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