Cleared Traditional

K903010 - CONTINUOUS VOLUME VENTILATOR MODEL LP10

K903010 is the FDA 510(k) clearance for CONTINUOUS VOLUME VENTILATOR MODEL LP10 by Aequitron Medical, Inc.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K903010 · Aequitron Medical, Inc. · Anesthesiology device
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Nov 1990
Decision
142d
Days
Class 2
Risk

K903010 is an FDA 510(k) clearance for the CONTINUOUS VOLUME VENTILATOR MODEL LP10. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Aequitron Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 30, 1990 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Aequitron Medical, Inc. devices

Submission Details

510(k) Number K903010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1990
Decision Date November 30, 1990
Days to Decision 142 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 140d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 120
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K903010.
NARKOMED AV-E VENTILATOR
K912533 · Draeger Medical, Inc. · Jul 1991
OHMEDA 7810 ANESTHESIA VENTILATOR
K910847 · Ohmeda Medical · May 1991
7200AE MICROPROCESSOR VENTILATOR W/ENHANCED HARD.
K902506 · Puritan Bennett Corp. · Jan 1991
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K902084 · Ohmeda Medical · Oct 1990
PURITAN-BENNETT COMPANION 2801 VOLUME VENTILATOR
K897113 · Puritan Bennett Corp. · Mar 1990
MODIFIED PERMCATH TRAY (2ND SUBMISSION)
K895779 · Quinton, Inc. · Dec 1989