Cleared Traditional

K983648 - SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM

K983648 is an FDA 510(k) clearance for SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM, manufactured by Perry Baromedical Services. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K983648 · Perry Baromedical Services · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
131d
Days
Class 2
Risk

K983648 is an FDA 510(k) clearance for the SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Perry Baromedical Services (Riviera Beach, US). The FDA issued a Cleared decision on February 24, 1999 after a review of 131 days - within the typical 510(k) review window.

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: 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 Perry Baromedical Services devices

FDA 510(k) Submission Details - K983648

510(k) Number K983648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1998
Decision Date February 24, 1999
Days to Decision 131 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
9d faster than avg
Panel avg: 140d · This submission: 131d
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 K983648.
SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER
K990927 · Perry Baromedical Corp. · Nov 1999
HTU3
K984313 · Hyox Systems , Ltd. · Oct 1999
TAMPA HYPERBARIC MONOPLACE CHAMBER
K981938 · Tampa Hyperbaric Ent. · Jul 1999
SANDS SERIES III HYPERBARIC CHAMBER
K972908 · Sands Hyperbarics · Jul 1998
SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
K974868 · Perry Baromedical Corp. · Jul 1998
WRIGHT 1000 MONOPLACE HYPERBARIC SYSTEM
K952545 · Wright Industries · May 1997