510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K803171Substantially Equivalent

Procedure & Recovery Patient Suit

Alba Health Care, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803171 is the FDA 510(k) clearance record for PROCEDURE & RECOVERY PATIENT SUIT, a class II device, cleared for Alba Health Care on under FDA product code FYB (Gown, Patient). FDA records list 8 510(k) clearances for Alba Health Care, from to . As of , FDA records show no recalls naming K803171.

Clearance record

Decision date
Received
(79 days to decision)
Product code
FYB Gown, Patient
Regulation
21 CFR 878.4040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Alba Health Care 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FYB

Trailing 12 months

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

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