Cleared Traditional

K852455 - GAMBRO DIGITAL TELETHERMOMETER TTH 10-200

K852455 is an FDA 510(k) clearance for GAMBRO DIGITAL TELETHERMOMETER TTH 10-200, manufactured by Gambro, Inc.. The device is a Class 1 Cardiovascular device with product code KRI cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K852455 · Gambro, Inc. · Cardiovascular device
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Sep 1985
Decision
98d
Days
Class 1
Risk

K852455 is an FDA 510(k) clearance for the GAMBRO DIGITAL TELETHERMOMETER TTH 10-200. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by Gambro, Inc. (Lincolnshire, US). The FDA issued a Cleared decision on September 16, 1985 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Gambro, Inc. devices

FDA 510(k) Submission Details - K852455

510(k) Number K852455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1985
Decision Date September 16, 1985
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

KRI Device Classification - Class 1, General Controls

Product Code KRI Accessory Equipment, Cardiopulmonary Bypass
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KRI Accessory Equipment, Cardiopulmonary Bypass

All 26
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K852455.
ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE
K862549 · American Bentley · Jul 1986
ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL
K860672 · American Bentley · Mar 1986
CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
K854113 · American Bentley · Jan 1986
COBE GAS FILTER
K851289 · Cobe Laboratories, Inc. · Jun 1985
TUBE TENDER
K841296 · The Anspach Effort, Inc. · Jun 1984
HOLDER FOR BOS-10, 10S 5S
K841812 · American Bentley · Jun 1984