510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K022609Substantially Equivalent

Surgical Patient Warmer, Model Pw820 Jhu

Fisher & Paykel Healthcare, Inc., East Tamaki, Auckland, NZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022609 is the FDA 510(k) clearance record for SURGICAL PATIENT WARMER, MODEL PW820 JHU, a class II device, cleared for Fisher & Paykel Healthcare, Ltd. on under FDA product code ILY (Lamp, Infrared, Therapeutic Heating). FDA records list 86 510(k) clearances for Fisher & Paykel Healthcare, Ltd., from to . As of , FDA records show no recalls naming K022609.

Clearance record

Decision date
Received
(212 days to decision)
Product code
ILY Lamp, Infrared, Therapeutic Heating
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Fisher & Paykel Healthcare, Ltd. 15 Maurice Paykel Pl., East Tamaki, Auckland, NZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ILY

Trailing 12 months
1 clearance under product code ILY in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ILY, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260