Cleared Traditional

K952545 - WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM

K952545 is an FDA 510(k) clearance for WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM, manufactured by Wright Industries. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 726-day FDA review.

K952545 · Wright Industries · Anesthesiology device
Download Printable Device Report (PDF)
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May 1997
Decision
726d
Days
Class 2
Risk

K952545 is an FDA 510(k) clearance for the WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Wright Industries (Gardena, US). The FDA issued a Cleared decision on May 28, 1997 after a review of 726 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - 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 Wright Industries devices

FDA 510(k) Submission Details - K952545

510(k) Number K952545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1995
Decision Date May 28, 1997
Days to Decision 726 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
586d slower than avg
Panel avg: 140d · This submission: 726d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBF Device Classification - Class 2, Special Controls

Product Code CBF Chamber, Hyperbaric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5470
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 - CBF Chamber, Hyperbaric

All 22
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K952545.
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
K983648 · Perry Baromedical Services · Feb 1999
SANDS SERIES III HYPERBARIC CHAMBER
K972908 · Sands Hyperbarics · Jul 1998
SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
K974868 · Perry Baromedical Corp. · Jul 1998
HYPERBARIC CHAMBER
K960389 · Tampa Hyperbaric Ent. · Dec 1996
GSP1 - GAS SELECTION PANEL
K962869 · Reimers Systems, Inc. · Oct 1996
ODS1 - HOOD DRIVER
K962871 · Reimers Systems, Inc. · Oct 1996