Cleared Traditional

K991087 - HANNAH WIRELESS VITAL SIGNS MONITOR

K991087 is an FDA 510(k) clearance for HANNAH WIRELESS VITAL SIGNS MONITOR, manufactured by Ilife Systems, Inc.. The device is a Class 2 Anesthesiology device with product code FLS cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K991087 · Ilife Systems, Inc. · Anesthesiology device
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Jan 2000
Decision
287d
Days
Class 2
Risk

K991087 is an FDA 510(k) clearance for the HANNAH WIRELESS VITAL SIGNS MONITOR. Classified as Monitor, Apnea, Facility Use (product code FLS), Class II - Special Controls.

Submitted by Ilife Systems, Inc. (Dallas, US). The FDA issued a Cleared decision on January 12, 2000 after a review of 287 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2377 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ilife Systems, Inc. devices

FDA 510(k) Submission Details - K991087

510(k) Number K991087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received March 31, 1999
Decision Date January 12, 2000
Days to Decision 287 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
147d slower than avg
Panel avg: 140d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLS Device Classification - Class 2, Special Controls

Product Code FLS Monitor, Apnea, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2377
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 - FLS Monitor, Apnea, Facility Use

All 7
Devices cleared under the same product code (FLS) and FDA review panel - the closest regulatory comparables to K991087.
REMBRANDT SYSTEM
K962865 · Airsep Corp. · Oct 1996
PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS
K951246 · Protocol Systems, Inc. · Feb 1996
RESPITRACE PLUS
K894973 · Hogan & Hartson · Oct 1989
RESPIRATION MONITOR
K832999 · Litton Medical Electronics · Feb 1984
CLINICAL DATA APNEA DETECTOR
K821721 · Clinical Data, Inc. · Jul 1982
INFUSION CONTROLLER, PARENTERAL
K781216 · National Patent Development Corp. · Aug 1978