510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832678Substantially Equivalent

Phonatory Function Analyzer Ps-77

Kells Medical, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832678 is the FDA 510(k) clearance record for PHONATORY FUNCTION ANALYZER PS-77, a class I device, cleared for Kells Medical, Inc. on under FDA product code BXP (Transducer, Gas Flow). FDA records list 12 510(k) clearances for Kells Medical, Inc., from to . As of , FDA records show no recalls naming K832678.

Clearance record

Decision date
Received
(211 days to decision)
Product code
BXP Transducer, Gas Flow
Regulation
21 CFR 868.2885
Device class
Class I
Review panel
Anesthesiology
Applicant
Kells Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code BXP

Trailing 12 months

FDA records hold no clearances under product code BXP in the trailing twelve months.

FDA records show no clearances under product code BXP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BXP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260