Cleared Traditional

K082657 - RTX RESPIRATOR

K082657 is an FDA 510(k) clearance for RTX RESPIRATOR, manufactured by Medivent Limited. The device is a Class 2 Anesthesiology device with product code BYT cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K082657 · Medivent Limited · Anesthesiology device
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Oct 2008
Decision
26d
Days
Class 2
Risk

K082657 is an FDA 510(k) clearance for the RTX RESPIRATOR. Classified as Ventilator, External Body, Negative Pressure, Adult (cuirass) (product code BYT), Class II - Special Controls.

Submitted by Medivent Limited (London, England, GB). The FDA issued a Cleared decision on October 8, 2008 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5935 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medivent Limited devices

FDA 510(k) Submission Details - K082657

510(k) Number K082657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2008
Decision Date October 08, 2008
Days to Decision 26 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 140d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

BYT Device Classification - Class 2, Special Controls

Product Code BYT Ventilator, External Body, Negative Pressure, Adult (cuirass)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5935
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 - BYT Ventilator, External Body, Negative Pressure, Adult (cuirass)

All 11
Devices cleared under the same product code (BYT) and FDA review panel - the closest regulatory comparables to K082657.
HAYEK OSCILLATOR(TM)
K924341 · Respironics, Inc. · Jul 1993
NEV-10 NEGATIVE PRESSURE VENTILATOR
K910947 · Lifecare Services, Inc. · Jun 1991
PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM
K905530 · Puritan Bennett Corp. · Mar 1991
EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
K902764 · J. H. Emerson Co. · Nov 1990
RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
K895849 · Respironics, Inc. · Dec 1989
EMERSON CHEST RESPIRATOR, MODEL 33-CRE
K881808 · J. H. Emerson Co. · Aug 1988