Cleared Traditional

K852238 - IPG-300

K852238 is an FDA 510(k) clearance for IPG-300, manufactured by Thornton Associates, Inc.. The device is a Class 2 Cardiovascular device with product code DSB cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K852238 · Thornton Associates, Inc. · Cardiovascular device
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Oct 1985
Decision
141d
Days
Class 2
Risk

K852238 is an FDA 510(k) clearance for the IPG-300. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Thornton Associates, Inc. (Washington, US). The FDA issued a Cleared decision on October 11, 1985 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - 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 Thornton Associates, Inc. devices

FDA 510(k) Submission Details - K852238

510(k) Number K852238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1985
Decision Date October 11, 1985
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSB Device Classification - Class 2, Special Controls

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSB Plethysmograph, Impedance

All 52
Devices cleared under the same product code (DSB) and FDA review panel - the closest regulatory comparables to K852238.
BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZER
K884033 · Biodynamics Corp. · Nov 1988
BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZER
K881968 · Biodynamics Corp. · Jul 1988
BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER
K874361 · Biodynamics Corp. · Mar 1988
CARDIAC WALL MOTION DEVICE
K833728 · Intl. Medical, Inc. · Feb 1984