Cleared Traditional

K981412 - M1145 (UPS1-1.25K-1G-MP) UPS

K981412 is an FDA 510(k) clearance for M1145 (UPS1-1.25K-1G-MP) UPS, manufactured by Clary Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K981412 · Clary Corp. · Anesthesiology device
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Nov 1998
Decision
217d
Days
Class 2
Risk

K981412 is an FDA 510(k) clearance for the M1145 (UPS1-1.25K-1G-MP) UPS. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Clary Corp. (Great Neck,, US). The FDA issued a Cleared decision on November 23, 1998 after a review of 217 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Clary Corp. devices

FDA 510(k) Submission Details - K981412

510(k) Number K981412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1998
Decision Date November 23, 1998
Days to Decision 217 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 140d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 367
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K981412.
PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION
K984535 · Puritan Bennett Corp. · Dec 1998
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM
K984379 · Puritan Bennett Corp. · Dec 1998
NEOFLOW OPTION MODEL NUMBERS 8413563, 8411900
K983219 · Drager, Inc. · Dec 1998
BEAR 1000, VEOLAR W LEONARDO GRAPHICS, BICORE CP-2000, BICORE CP-100, HI-LO JET ET TUBE
K983981 · Bear Medical Systems, Inc. · Nov 1998
ESPRIT VENTILATOR
K981072 · Respironics, Inc. · Nov 1998
LTV 1000 VENTILATOR
K981371 · Pulmonetic Systems, Inc. · Oct 1998