Cleared Special

K010704 - DORNIR LC-1 CPAP SYSTEM

K010704 is an FDA 510(k) clearance for DORNIR LC-1 CPAP SYSTEM, manufactured by Prym Medical , Ltd.. The device is a Class 2 Anesthesiology device with product code BZD cleared through the Special 510(k) pathway after a 40-day FDA review.

K010704 · Prym Medical , Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
40d
Days
Class 2
Risk

K010704 is an FDA 510(k) clearance for the DORNIR LC-1 CPAP SYSTEM. Classified as Ventilator, Non-continuous (respirator) (product code BZD), Class II - Special Controls.

Submitted by Prym Medical , Ltd. (Ra'Ananna 43373, IL). The FDA issued a Cleared decision on April 18, 2001 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K010704

510(k) Number K010704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2001
Decision Date April 18, 2001
Days to Decision 40 days
Submission Type Special
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
100d faster than avg
Panel avg: 140d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

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 462
Devices cleared under the same product code (BZD) and FDA review panel - the closest regulatory comparables to K010704.
ORACLE ORAL MASK
K003894 · Fisher &Paykel Healthcare , Ltd. · Jun 2001
INFANT FLOW SYSTEM, MODEL M672P
K011516 · Eme (Electro Medical Equipment) , Ltd. · Jun 2001
REMREST
K002763 · Medical Industries America, Inc. · May 2001
REMSTAR PLUS CPAP SYSTEM
K010263 · Respironics, Inc. · Mar 2001
AERO-CLICK
K993094 · Map Medizintechnik Fur Arzt Und Patient GmbH · Oct 2000
RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223
K000705 · Respironics, Inc. · Sep 2000
K010704 · DORNIR LC-1 CPAP SYSTEM
Download PDF FDA Summary Prym Medical , Ltd.