510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K854151Substantially Equivalent

Homecare Clinics Infraheat #230

Nelkin/Piper Intl., Kansas City MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854151 is the FDA 510(k) clearance record for HOMECARE CLINICS INFRAHEAT #230, a class II device, cleared for Nelkin/Piper Intl. on under FDA product code ILY (Lamp, Infrared, Therapeutic Heating). FDA records list one 510(k) clearance for Nelkin/Piper Intl. As of , FDA records show no recalls naming K854151.

Clearance record

Decision date
Received
(111 days to decision)
Product code
ILY Lamp, Infrared, Therapeutic Heating
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Nelkin/Piper Intl. 811 Wyandotte, Kansas City MO
Third party review
No

Clearances, product code ILY

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