Cleared Traditional

AERO-CLICK (K993094) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K993094 · Map Medizintechnik Fur Arzt Und Patient GmbH · Anesthesiology device
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Oct 2000
Decision
403d
Days
Class 2
Risk

K993094 is an FDA 510(k) clearance for the AERO-CLICK. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Map Medizintechnik Fur Arzt Und Patient GmbH (Martinsried, DE). The FDA issued a Cleared decision on October 23, 2000 after a review of 403 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Map Medizintechnik Fur Arzt Und Patient GmbH devices

Submission Details

510(k) Number K993094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1999
Decision Date October 23, 2000
Days to Decision 403 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
263d slower than avg
Panel avg: 140d · This submission: 403d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZD Ventilator, Non-continuous (respirator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - BZD Ventilator, Non-continuous (respirator)

All 131
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K993094.
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RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
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BREEZE SLEEPGEAR WITH DREAMSEAL
K002001 · Puritan Bennett Corp. · Sep 2000