Cleared Traditional

K896536 - PHARMATRONICS NEBULIZER

K896536 is an FDA 510(k) clearance for PHARMATRONICS NEBULIZER, manufactured by Diversatronics, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K896536 · Diversatronics, Inc. · Anesthesiology device
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Jul 1990
Decision
250d
Days
Class 2
Risk

K896536 is an FDA 510(k) clearance for the PHARMATRONICS NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Diversatronics, Inc. (Broomall, US). The FDA issued a Cleared decision on July 23, 1990 after a review of 250 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 Diversatronics, Inc. devices

FDA 510(k) Submission Details - K896536

510(k) Number K896536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1989
Decision Date July 23, 1990
Days to Decision 250 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 140d · This submission: 250d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 406
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K896536.
WATER COLUMN RELIEF VALVE
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MINI-MICRON CIRCUIT
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TRACH CARE MDI ADAPTER
K900273 · Ballard Medical Products · Aug 1990
MDI ADAPTOR
K900783 · Hudson Oxygen Therapy Sales Co. · Jul 1990
ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE
K901362 · Automatic Liquid Packaging, Inc. · Jun 1990
STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL
K901301 · Automatic Liquid Packaging, Inc. · May 1990