Cleared Traditional

K990927 - SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER

K990927 is an FDA 510(k) clearance for SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER, manufactured by Perry Baromedical Corp.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K990927 · Perry Baromedical Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
238d
Days
Class 2
Risk

K990927 is an FDA 510(k) clearance for the SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Perry Baromedical Corp. (Rivera Beach, US). The FDA issued a Cleared decision on November 12, 1999 after a review of 238 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K990927

510(k) Number K990927 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1999
Decision Date November 12, 1999
Days to Decision 238 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
98d slower than avg
Panel avg: 140d · This submission: 238d
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 56
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K990927.
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
K002795 · Hypertec, Inc. · Dec 2000
GAMOW BAG, HYPER OXY, HYPER OXY P/T, PRESSURE-CIZER
K001409 · Hyperbaric Technologies, Inc. · Aug 2000
BARA-MED, ACRYLIC MONOPLACE HYPERBARIC CHAMBER
K993010 · Environmental Tectonics Corp. · May 2000
HTU3
K984313 · Hyox Systems , Ltd. · Oct 1999
TAMPA HYPERBARIC MONOPLACE CHAMBER
K981938 · Tampa Hyperbaric Ent. · Jul 1999
SIGMA PLUS/ II MULTIPLACE HYPERBARIC SYSTEM
K983648 · Perry Baromedical Services · Feb 1999