510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K063759Substantially Equivalent

Heatmarker Time Temperature Indicator

Temptime Corporation, Morris Plains NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063759 is the FDA 510(k) clearance record for HEATMARKER TIME TEMPERATURE INDICATOR, a class II device, cleared for Temptime Corporation on under FDA product code OCI (Indicator, Physical/Chemical, Storage Temperature). FDA's definition for product code OCI reads: "The time-temperature indicator provides a visual signal that a selected time-temperature profile has been exceeded. When affixed to a device, a time temperature indicator is indicated, via a permanent color change, for the purpose of...". FDA records list one 510(k) clearance for Temptime Corporation. As of , FDA records show no recalls naming K063759.

Clearance record

Decision date
Received
(239 days to decision)
Product code
OCI Indicator, Physical/Chemical, Storage Temperature
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Applicant
Temptime Corporation 116 American Rd., Morris Plains NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OCI

Trailing 12 months

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

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