510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822286Substantially Equivalent

Autocuff (Photos Enclosed with 510K

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

K822286 is the FDA 510(k) clearance record for AUTOCUFF (PHOTOS ENCLOSED WITH 510K, a class I device, cleared for Partamed, Inc. on under FDA product code KZD (Infusor, Pressure, For I.V. Bags). FDA records list one 510(k) clearance for Partamed, Inc. As of , FDA records show no recalls naming K822286.

Clearance record

Decision date
Received
(28 days to decision)
Product code
KZD Infusor, Pressure, For I.V. Bags
Regulation
21 CFR 880.5420
Device class
Class I
Review panel
General Hospital
Applicant
Partamed, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KZD

Trailing 12 months

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

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