Cleared Traditional

K895513 - PERRY SV-1 HYPERBARIC VENTILATOR

K895513 is an FDA 510(k) clearance for PERRY SV-1 HYPERBARIC VENTILATOR, manufactured by Perry Baromedical Services. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 463-day FDA review.

K895513 · Perry Baromedical Services · Anesthesiology device
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Dec 1990
Decision
463d
Days
Class 2
Risk

K895513 is an FDA 510(k) clearance for the PERRY SV-1 HYPERBARIC VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Perry Baromedical Services (Riviera Beach, US). The FDA issued a Cleared decision on December 19, 1990 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Perry Baromedical Services devices

FDA 510(k) Submission Details - K895513

510(k) Number K895513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1989
Decision Date December 19, 1990
Days to Decision 463 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
323d slower than avg
Panel avg: 140d · This submission: 463d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

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 351
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K895513.
ADULT STAR, MODIFICATION
K905272 · Infrasonics Corp. · Jan 1991
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K902506 · Puritan Bennett Corp. · Jan 1991
AIROX AXR. 1A
K901953 · Ferguson Medical · Jan 1991
CONTINUOUS VOLUME VENTILATOR MODEL LP10
K903010 · Aequitron Medical, Inc. · Nov 1990
MODEL LP6 VENTILATOR, MODIFICATION
K905244 · Aequitron Medical, Inc. · Nov 1990
OHMEDA 7800 ANESTHESIA VENTILATOR SOFTWARE UPDATE
K902084 · Ohmeda Medical · Oct 1990