510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K802561Substantially Equivalent

Hi Volume Pumping Chamber

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

K802561 is the FDA 510(k) clearance record for HI VOLUME PUMPING CHAMBER, a class I device, cleared for Acacia, Inc. on under FDA product code JTB (Device, Media Dispensing/Stacking). FDA records list 17 510(k) clearances for Acacia, Inc., from to . As of , FDA records show no recalls naming K802561.

Clearance record

Decision date
Received
(15 days to decision)
Product code
JTB Device, Media Dispensing/Stacking
Regulation
21 CFR 866.2440
Device class
Class I
Review panel
Microbiology
Applicant
Acacia, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JTB

Trailing 12 months

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

FDA records show no clearances under product code JTB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JTB, 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