Cleared Traditional

K013251 - SPIRIT 300

K013251 is an FDA 510(k) clearance for SPIRIT 300, manufactured by Caire, Inc.. The device is a Class 2 Anesthesiology device with product code BYJ cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K013251 · Caire, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Dec 2001
Decision
81d
Days
Class 2
Risk

K013251 is an FDA 510(k) clearance for the SPIRIT 300. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Caire, Inc. (Burnsville, US). The FDA issued a Cleared decision on December 18, 2001 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5655 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Caire, Inc. devices

FDA 510(k) Submission Details - K013251

510(k) Number K013251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2001
Decision Date December 18, 2001
Days to Decision 81 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 140d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

BYJ Device Classification - Class 2, Special Controls

Product Code BYJ Unit, Liquid-oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5655
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 Consultant

Tuv Product Service, Inc.
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BYJ Unit, Liquid-oxygen, Portable

All 30
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K013251.
SPIRIT, MODEL HAS
K050153 · Caire, Inc. · Apr 2005
PLIX
K050414 · Respironics, Inc. · Apr 2005
PRECISION LIQUID OXYGEN SYSTEM
K041122 · Precision Medical, Inc. · Oct 2004
PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
K993220 · Puritan Bennett Corp. · Oct 1999
PROTEGE LIQUID OXYGEN SYSTEM
K971545 · Healthdyne Technologies, Inc. · Jul 1997
PORTABLE LIQUID OXYGEN UNIT AND STATIONARY LIQUID OXYGEN UNIT
K963956 · Southern Research, Inc. · Dec 1996