Cleared Traditional

K952429 - RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM

K952429 is an FDA 510(k) clearance for RES CARE AUTO SET CLINICAL, manufactured by Rescare , Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 405-day FDA review.

K952429 · Rescare , Ltd. · Anesthesiology device
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Jul 1996
Decision
405d
Days
Class 2
Risk

K952429 is an FDA 510(k) clearance for the RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Rescare , Ltd. (Lajolla, US). The FDA issued a Cleared decision on July 2, 1996 after a review of 405 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Rescare , Ltd. devices

FDA 510(k) Submission Details - K952429

510(k) Number K952429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1995
Decision Date July 02, 1996
Days to Decision 405 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
265d slower than avg
Panel avg: 140d · This submission: 405d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZD Device Classification - Class 2, Special Controls

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 391
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K952429.
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THE IMS DPAP MASK, IMS MODEL NUMBER 82000
K953697 · Sleepnet Corporation · Jun 1996
SULLIVAN NOSE & MOUTH MASK SYSTEM
K952475 · Rescare , Ltd. · May 1996