510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850045Substantially Equivalent

Spirometrics 2453 & Smi III

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

K850045 is the FDA 510(k) clearance record for SPIROMETRICS 2453 & SMI III, a class II device, cleared for Spirometrics, Inc. on under FDA product code BTY (Calculator, Predicted Values, Pulmonary Function). FDA records list 11 510(k) clearances for Spirometrics, Inc., from to . As of , FDA records show no recalls naming K850045.

Clearance record

Decision date
Received
(38 days to decision)
Product code
BTY Calculator, Predicted Values, Pulmonary Function
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Spirometrics, Inc. 26 Essex St., Andover MA
Third party review
No

Clearances, product code BTY

Trailing 12 months
1 clearance under product code BTY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260