Cleared Traditional

K913327 - CONTEMPRO2 HOME HEALTH CARE REGULATOR

K913327 is the FDA 510(k) clearance for CONTEMPRO2 HOME HEALTH CARE REGULATOR by Continental Products, Inc.. It is a Class 2 Anesthesiology device (product code CAW) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K913327 · Continental Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1991
Decision
148d
Days
Class 2
Risk

K913327 is an FDA 510(k) clearance for the CONTEMPRO2 HOME HEALTH CARE REGULATOR. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Continental Products, Inc. (Portland, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Continental Products, Inc. devices

Submission Details

510(k) Number K913327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date December 20, 1991
Days to Decision 148 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 140d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAW Generator, Oxygen, Portable

All 67
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K913327.
MODIFICATION TO VENTURE IHO 100 COMPLETE HOME OXYGEN SYSTEM
K983777 · Invacare Corp. · Dec 1998
MOBILAIRE V & III PRO2 OXYGEN SENSORS FEATURES
K924818 · Invacare Corp. · Aug 1993
MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS
K914488 · Invacare Corp. · Sep 1992
MOBILAIRE III AND V MODEL IRC 301 AND 501 OXY. CON
K904087 · Invacare Corp. · Oct 1990
V-LINK
K903608 · GE Medical Systems · Oct 1990
PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR
K895177 · Puritan Bennett Corp. · Nov 1989