510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042532Substantially Equivalent

Biocare Systems Premir 818

Biocare Systems, Inc., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042532 is the FDA 510(k) clearance record for BIOCARE SYSTEMS PREMIR 818, a class II device, cleared for Biocare Systems, Inc. on under FDA product code ILY (Lamp, Infrared, Therapeutic Heating). FDA records list 2 510(k) clearances for Biocare Systems, Inc., from to . As of , FDA records show no recalls naming K042532.

Clearance record

Decision date
Received
(87 days to decision)
Product code
ILY Lamp, Infrared, Therapeutic Heating
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Applicant
Biocare Systems, Inc. 518 17th St., Denver CO
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 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