Cleared Traditional

K831337 - COMPRESSAR DISPOSABLE DISC

K831337 is an FDA 510(k) clearance for COMPRESSAR DISPOSABLE DISC, manufactured by Instromedix, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K831337 · Instromedix, Inc. · Cardiovascular device
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Jul 1983
Decision
85d
Days
Class 2
Risk

K831337 is an FDA 510(k) clearance for the COMPRESSAR DISPOSABLE DISC. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Instromedix, Inc.. The FDA issued a Cleared decision on July 19, 1983 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instromedix, Inc. devices

FDA 510(k) Submission Details - K831337

510(k) Number K831337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1983
Decision Date July 19, 1983
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 306
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K831337.
ELECATH HEPARIN-COATED CATHETERS
K841615 · Electro-Catheter Corp. · Jun 1984
DIAGNOSTIC RADIOLOGY CATHETERS
K834459 · American Edwards Laboratories · Feb 1984
PERCLUDER DL OCCLUDING BALLOON
K832386 · Datascope Corp. · Oct 1983
ANGIOGRAPHY KIT W/ADDIT. COMPONENTS
K831509 · Mallinckrodt Critical Care · Jun 1983
DIGICATH
K831171 · Argon Medical Corp. · May 1983
ANGIOGRAPHIC NEEDLE
K831189 · Medrad, Inc. · May 1983