510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081693Substantially Equivalent

Ns Series Nif (Negative Inspiratory Force) Meters

Instrumentation Industries, Incorporated, Bethel Park PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081693 is the FDA 510(k) clearance record for NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS, a class II device, cleared for Instrumentation Industries, Inc. on under FDA product code BXR (Meter, Airway Pressure (Inspiratory Force)). FDA records list 45 510(k) clearances for INSTRUMENTATION INDUSTRIES, INCORPORATED, from to . As of , FDA records show no recalls naming K081693.

Clearance record

Decision date
Received
(86 days to decision)
Product code
BXR Meter, Airway Pressure (Inspiratory Force)
Regulation
21 CFR 868.1780
Device class
Class II
Review panel
Anesthesiology
Applicant
Instrumentation Industries, Inc. 2990 Industrial Blvd., Bethel Park PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BXR

Trailing 12 months

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

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