Cleared Traditional

K924709 - SATCARE OXYGEN CONTROLLER/MONITOR W/ PU...

K924709 is an FDA 510(k) clearance for SATCARE OXYGEN CONTROLLER/MONITOR W/ PU..., manufactured by Air-Shields, Inc.. The device is a Class 2 Anesthesiology device with product code KLK cleared through the Traditional 510(k) pathway after a 1216-day FDA review.

K924709 · Air-Shields, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
1216d
Days
Class 2
Risk

K924709 is an FDA 510(k) clearance for the SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Air-Shields, Inc. (Hatboro, US). The FDA issued a Cleared decision on January 17, 1996 after a review of 1216 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2500 - 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 Air-Shields, Inc. devices

FDA 510(k) Submission Details - K924709

510(k) Number K924709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 1992
Decision Date January 17, 1996
Days to Decision 1216 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
1076d slower than avg
Panel avg: 140d · This submission: 1216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLK Device Classification - Class 2, Special Controls

Product Code KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2500
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 - KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

All 32
Devices cleared under the same product code (KLK) and FDA review panel - the closest regulatory comparables to K924709.
SIEMENS SC9000/SC9015 TCP02/C02 MODULE
K980287 · Siemens Medical Solutions USA, Inc. · Aug 1998
HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE
K925910 · Hewlett-Packard Co. · Jul 1993
HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX
K893133 · Mennen Medical, Inc. · Jul 1989
MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR
K870805 · Novametrix Medical Systems, Inc. · May 1987
515A NEO-TRAK NEONATAL MONITOR
K861861 · Ge Medical Systems Information Technologies · Jul 1986
HORIZON 2000 TRANSCUTANEOUS GAS MONITORING
K860124 · Mennen Medical, Inc. · May 1986