510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K895575Substantially Equivalent

Bio-Rad Modular Air Compressor

Bio-Rad, Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895575 is the FDA 510(k) clearance record for BIO-RAD MODULAR AIR COMPRESSOR, a class II device, cleared for Bio-Rad on under FDA product code HKX (Tonometer, Ac-Powered). FDA records list 319 510(k) clearances for Bio-Rad, from to . As of , FDA records show no recalls naming K895575.

Clearance record

Decision date
Received
(47 days to decision)
Product code
HKX Tonometer, Ac-Powered
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Bio-Rad 237 Putnam Ave., Cambridge MA
Third party review
No

Clearances, product code HKX

Trailing 12 months

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

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