510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K934475Substantially Equivalent

Koko Filter II

Pulmonary Data Services Inst., Inc., Louisville CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K934475 is the FDA 510(k) clearance record for KOKO FILTER II, a class II device, cleared for Pulmonary Data Services Inst., Inc. on under FDA product code CAH (Filter, Bacterial, Breathing-Circuit). FDA records list one 510(k) clearance for Pulmonary Data Services Inst., Inc. As of , FDA records show no recalls naming K934475.

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
Pulmonary Data Services Inst., Inc. P.O. Box 400, Louisville CO
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