Cleared Traditional

K072290 - PEGASO V

K072290 is an FDA 510(k) clearance for PEGASO V, manufactured by Dima Italia Srl. The device is a Class 2 Anesthesiology device with product code BYT cleared through the Traditional 510(k) pathway after a 287-day FDA review.

K072290 · Dima Italia Srl · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
287d
Days
Class 2
Risk

K072290 is an FDA 510(k) clearance for the PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS. Classified as Ventilator, External Body, Negative Pressure, Adult (cuirass) (product code BYT), Class II - Special Controls.

Submitted by Dima Italia Srl (Boulder, US). The FDA issued a Cleared decision on May 29, 2008 after a review of 287 days - an extended review 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: 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 Dima Italia Srl devices

FDA 510(k) Submission Details - K072290

510(k) Number K072290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2007
Decision Date May 29, 2008
Days to Decision 287 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
147d slower than avg
Panel avg: 140d · This submission: 287d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K072290.
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