Cleared Traditional

K973314 - SPIROSAFE FILTER

K973314 is an FDA 510(k) clearance for SPIROSAFE FILTER, manufactured by Micro Direct, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K973314 · Micro Direct, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
79d
Days
Class 2
Risk

K973314 is an FDA 510(k) clearance for the SPIROSAFE FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Micro Direct, Inc. (Lewiston, US). The FDA issued a Cleared decision on November 21, 1997 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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 Micro Direct, Inc. devices

FDA 510(k) Submission Details - K973314

510(k) Number K973314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1997
Decision Date November 21, 1997
Days to Decision 79 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 129d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 114
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K973314.
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER
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72 HOUR USE TRACH CARE WITH MICROBAN
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FILTER
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HUMID-VENT FILTER COMPACT ANGLED (18402)/HUMID-VENT FILTER COMPACT STRAIGHT(19402)
K964382 · Gibeck, Inc. · Apr 1997
POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER
K965020 · Porous Media Corp. · Mar 1997