Cleared Special

K992986 - SALTER LABS SINGLE PATIENT USE EXHALATI...

K992986 is an FDA 510(k) clearance for SALTER LABS SINGLE PATIENT USE EXHALATI..., manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 21-day FDA review.

K992986 · Salter Labs · Anesthesiology device
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Sep 1999
Decision
21d
Days
Class 2
Risk

K992986 is an FDA 510(k) clearance for the SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Salter Labs (Arvin, US). The FDA issued a Cleared decision on September 24, 1999 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Salter Labs devices

FDA 510(k) Submission Details - K992986

510(k) Number K992986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1999
Decision Date September 24, 1999
Days to Decision 21 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 140d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 190
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K992986.
METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE
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SALTER LABS PEP DEVICE
K991788 · Salter Labs · Aug 1999
AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD
K982722 · Ambu, Inc. · Apr 1999
SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER
K983403 · Salter Labs · Dec 1998