510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K101629Substantially Equivalent

Fil 1520

Glenn Medical Systems, Inc., Ne Canton OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K101629 is the FDA 510(k) clearance record for FIL 1520, a class II device, cleared for Glenn Medical Systems, Inc. on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list one 510(k) clearance for Glenn Medical Systems, Inc. As of , FDA records show no recalls naming K101629.

Clearance record

Decision date
Received
(29 days to decision)
Product code
CAH Filter, Bacterial, Breathing-Circuit
Regulation
21 CFR 868.5260
Device class
Class II
Review panel
Anesthesiology
Applicant
Glenn Medical Systems, Inc. 511 12th St., NE, Ne Canton OH
510(k) summary
Statement
Third party review
Yes

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