Cleared Traditional

K993094 - AERO-CLICK

K993094 is an FDA 510(k) clearance for AERO-CLICK, manufactured by Map Medizintechnik Fur Arzt Und Patient GmbH. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 403-day FDA review.

K993094 · Map Medizintechnik Fur Arzt Und Patient GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K993094

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.

BZD Device Classification - Class 2, Special Controls

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 307
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K993094.
ORACLE ORAL MASK
K003894 · Fisher &Paykel Healthcare , Ltd. · Jun 2001
REMREST
K002763 · Medical Industries America, Inc. · May 2001
REMSTAR PLUS CPAP SYSTEM
K010263 · Respironics, Inc. · Mar 2001
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
K000705 · Respironics, Inc. · Sep 2000
SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876
K002465 · Respironics, Inc. · Sep 2000
BREEZE SLEEPGEAR WITH DREAMSEAL
K002001 · Puritan Bennett Corp. · Sep 2000