Cleared Traditional

VITALERT 3000 MONITORING SYSTEM (K913995) - FDA 510(k) Clearance

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

K913995 · Draeger Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
424d
Days
Class 2
Risk

K913995 is an FDA 510(k) clearance for the VITALERT 3000 MONITORING SYSTEM. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on November 3, 1992 after a review of 424 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Draeger Medical, Inc. devices

Submission Details

510(k) Number K913995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1991
Decision Date November 03, 1992
Days to Decision 424 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
284d slower than avg
Panel avg: 140d · This submission: 424d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

All 68
Devices cleared under the same product code (CCK) and FDA review panel - the closest regulatory comparables to K913995.
HP M1465A STANDARD AIRWAY ADAPTER
K933980 · Hewlett-Packard Co. · Sep 1993
RASCAL II
K930866 · Ohmeda Medical · May 1993
MASS SPECTROMETRY MONITORING LINE CONONECTORS
K925167 · Merit Medical Systems, Inc. · Jan 1993
DATASCOPE PASSPORT MONITOR WITH CO2
K921526 · Datascope Corp. · Oct 1992
RASCAL II
K920622 · Ohmeda Medical · Oct 1992
OHMEDA MODEL 5250 RGM MONITOR
K920590 · Ohmeda Medical · Aug 1992