Cleared Traditional

K934509 - PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER

K934509 is an FDA 510(k) clearance for PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER, manufactured by Sdi Diagnostics, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K934509 · Sdi Diagnostics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
37d
Days
Class 2
Risk

K934509 is an FDA 510(k) clearance for the PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Sdi Diagnostics, Inc. (North Easton, US). The FDA issued a Cleared decision on October 21, 1993 after a review of 37 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 Sdi Diagnostics, Inc. devices

FDA 510(k) Submission Details - K934509

510(k) Number K934509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1993
Decision Date October 21, 1993
Days to Decision 37 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 129d · This submission: 37d
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 91
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K934509.
BARRIERBAC AND BARRIERBAC S
K941536 · Mallinckrodt Medical · Apr 1994
HYGROBAC,S HYGROBOY AND HYGROBABY
K941381 · Mallinckrodt Medical · Apr 1994
SENSORMEDICS MICROGARD MICROBIAL FILTER
K934272 · Sensor Medics Corp. · Nov 1993
HEPA FILTERED HME
K930816 · Intertech Resources, Inc. · Jul 1993
MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
K925217 · Merit Medical Systems, Inc. · Jan 1993
VENTILATOR CIRCUITS
K920885 · Vital Signs, Inc. · Oct 1992