510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K863953Substantially Equivalent

Spirometrics Model 2500 Flowmate(tm)

Spirometrics, Inc., Arlington VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863953 is the FDA 510(k) clearance record for SPIROMETRICS MODEL 2500 FLOWMATE(TM), a class II device, cleared for Spirometrics, Inc. on under FDA product code BZM (Calculator, Pulmonary Function Interpretor (Diagnostic)). FDA records list 11 510(k) clearances for Spirometrics, Inc., from to . As of , FDA records show no recalls naming K863953.

Clearance record

Decision date
Received
(97 days to decision)
Product code
BZM Calculator, Pulmonary Function Interpretor (Diagnostic)
Regulation
21 CFR 868.1900
Device class
Class II
Review panel
Anesthesiology
Applicant
Spirometrics, Inc. Suite 1203 Crystal Plz. Bldg1, Arlington VA
Third party review
No

Clearances, product code BZM

Trailing 12 months

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

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