Cleared Traditional

K120285 - K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER

K120285 is an FDA 510(k) clearance for K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER, manufactured by Curative Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K120285 · Curative Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
153d
Days
Class 2
Risk

K120285 is an FDA 510(k) clearance for the K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Curative Medical, Inc. (Lake Jackson, US). The FDA issued a Cleared decision on July 2, 2012 after a review of 153 days - an extended review cycle.

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: 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 Curative Medical, Inc. devices

FDA 510(k) Submission Details - K120285

510(k) Number K120285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2012
Decision Date July 02, 2012
Days to Decision 153 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
13d slower than avg
Panel avg: 140d · This submission: 153d
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 K120285.
SIMPLE T NASAL MASK
K121631 · Respironics, Inc. · Oct 2012
MOJO, VERASEAL
K120463 · Sleepnet Corporation · Jul 2012
PERFORMAX PEDIATRIC EE TOTAL FACE MASK
K120562 · Respironics, Inc. · Jul 2012
APEX MEDICAL ICH CPAP SERIES (9S-007XXX)
K120035 · Apex Medical Corp. · May 2012
EASYCARE TX SYSTEM (CONNEXUNS)
K113780 · Resmed, Ltd. · Apr 2012
SIMPLE T NASAL MASK
K120145 · Respironics, Inc. · Mar 2012