Cleared Traditional

K982408 - AEROTEE, MODEL # 1001

K982408 is an FDA 510(k) clearance for AEROTEE, manufactured by Piper Medical Products. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K982408 · Piper Medical Products · Anesthesiology device
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Sep 1998
Decision
66d
Days
Class 2
Risk

K982408 is an FDA 510(k) clearance for the AEROTEE, MODEL # 1001. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Piper Medical Products (Sacramento, US). The FDA issued a Cleared decision on September 14, 1998 after a review of 66 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 Piper Medical Products devices

FDA 510(k) Submission Details - K982408

510(k) Number K982408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1998
Decision Date September 14, 1998
Days to Decision 66 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 140d · This submission: 66d
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 318
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K982408.
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K980074 · Project Marketing · Jun 1998