510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K870113Substantially Equivalent

Thermal Jacket for i.v. Fluid Bags

Thermal Medical Systems, Inc., Astoria OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870113 is the FDA 510(k) clearance record for THERMAL JACKET FOR I.V. FLUID BAGS, a class II device, cleared for Thermal Medical Systems, Inc. on under FDA product code KPE (Container, I.V.). FDA records list one 510(k) clearance for Thermal Medical Systems, Inc. As of , FDA records show no recalls naming K870113.

Clearance record

Decision date
Received
(44 days to decision)
Product code
KPE Container, I.V.
Regulation
21 CFR 880.5025
Device class
Class II
Review panel
General Hospital
Applicant
Thermal Medical Systems, Inc. Rt. 2 Box 147, Astoria OR
Third party review
No

Clearances, product code KPE

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