510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013123Substantially Equivalent

Ems Pulmonary Function Testing Filter

Engineered Medical Systems, LLC, Mccordsville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013123 is the FDA 510(k) clearance record for EMS PULMONARY FUNCTION TESTING FILTER, a class II device, cleared for Engineered Medical Systems on under FDA product code BZG (Spirometer, Diagnostic). FDA records list 25 510(k) clearances for Engineered Medical Systems, from to . As of , FDA records show no recalls naming K013123.

Clearance record

Decision date
Received
(176 days to decision)
Product code
BZG Spirometer, Diagnostic
Regulation
21 CFR 868.1840
Device class
Class II
Review panel
Anesthesiology
Applicant
Engineered Medical Systems 6329 W. Waterview Ct., Mccordsville IN
510(k) summary
Summary
Third party review
No

Clearances, product code BZG

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