510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K934509Substantially Equivalent

Pulmoguard Disposable Baterial/viral Filter

Sdi Diagnostics, Inc., North Easton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934509 is the FDA 510(k) clearance record for PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER, a class II device, cleared for Sdi Diagnostics, Inc. on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list 10 510(k) clearances for Sdi Diagnostics, Inc., from to . As of , FDA records show no recalls naming K934509.

Clearance record

Decision date
Received
(37 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Sdi Diagnostics, Inc. Shovel Shop Sq., North Easton MA
510(k) summary
Summary
Third party review
No

Clearances, product code CAH

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