Cleared Traditional

K884465 - SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM)

K884465 is an FDA 510(k) clearance for SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM), manufactured by Spirometrics, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K884465 · Spirometrics, Inc. · General Hospital
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Nov 1988
Decision
16d
Days
Class 2
Risk

K884465 is an FDA 510(k) clearance for the SPIROMETRICS MODEL 2141 SPIRO-FILTER(TM). Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Spirometrics, Inc. (Auburn, US). The FDA issued a Cleared decision on November 9, 1988 after a review of 16 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 Spirometrics, Inc. devices

FDA 510(k) Submission Details - K884465

510(k) Number K884465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1988
Decision Date November 09, 1988
Days to Decision 16 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 129d · This submission: 16d
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 152
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K884465.
RCI VIRAL/BACTERIAL FILTER
K892230 · Respiratory Care, Inc. · Aug 1989
BACTERIA FILTER
K890035 · Hudson Oxygen Therapy Sales Co. · May 1989
OMNIFILTER MAIN FLOW BACTERIA FILTER
K890362 · Puritan Bennett Corp. · Mar 1989
RESUSCITATION BAG EXHALATION FILTER
K883693 · Intertech Resources, Inc. · Sep 1988
MINI-FILTER, VIROBAC II
K880681 · King Systems Corp. · Apr 1988
SIEMENS MAIN FLOW BACTERIA FILTER
K871366 · Siemens Elema AB · May 1987