Cleared Traditional

K951926 - ALRECO 40400

K951926 is an FDA 510(k) clearance for ALRECO 40400, manufactured by Allan Rehnstrom AB. The device is a Class 2 Anesthesiology device with product code BTI cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K951926 · Allan Rehnstrom AB · Anesthesiology device
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Dec 1995
Decision
227d
Days
Class 2
Risk

K951926 is an FDA 510(k) clearance for the ALRECO 40400. Classified as Compressor, Air, Portable (product code BTI), Class II - Special Controls.

Submitted by Allan Rehnstrom AB (Osterbagen 5, SE). The FDA issued a Cleared decision on December 8, 1995 after a review of 227 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6250 - 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 Allan Rehnstrom AB devices

FDA 510(k) Submission Details - K951926

510(k) Number K951926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1995
Decision Date December 08, 1995
Days to Decision 227 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 140d · This submission: 227d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTI Device Classification - Class 2, Special Controls

Product Code BTI Compressor, Air, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.6250
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 - BTI Compressor, Air, Portable

All 41
Devices cleared under the same product code (BTI) and FDA review panel - the closest regulatory comparables to K951926.
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