Cleared Traditional

K851436 - NEBULAIRE (IRC 1040) NEBULIZER PUMP

K851436 is an FDA 510(k) clearance for NEBULAIRE (IRC 1040) NEBULIZER PUMP, manufactured by Invacare Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K851436 · Invacare Corp. · Anesthesiology device
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Jul 1985
Decision
89d
Days
Class 2
Risk

K851436 is an FDA 510(k) clearance for the NEBULAIRE (IRC 1040) NEBULIZER PUMP. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on July 8, 1985 after a review of 89 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. 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 Invacare Corp. devices

FDA 510(k) Submission Details - K851436

510(k) Number K851436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1985
Decision Date July 08, 1985
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 140d · This submission: 89d
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 191
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K851436.
ASTHMAKIT
K874047 · Dhd Medical Products Div. Diemolding Corp. · Feb 1988
RESPIRGARD II NEBULIZER SYSTEM
K874395 · Marquest Medical Products, Inc. · Dec 1987
SERVO NEBULIZER 945 SIEMENS-ELEMA AB
K871293 · Siemens Elema AB · May 1987
VARIABLE NEBULIZER HEATER
K851074 · Travenol Laboratories, S.A. · Jun 1985
SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN
K834077 · Airlife, Inc. · Dec 1983
NEBULIZER ACCESSORY FOR SERVO VENTILL
K832898 · Siemens Elema AB · Nov 1983