Cleared Traditional

K771668 - DISP. FLUID ISOLATOR & PRESS. RELIEF

K771668 is an FDA 510(k) clearance for DISP. FLUID ISOLATOR & PRESS. RELIEF, manufactured by Ailtech. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K771668 · Ailtech · Cardiovascular device
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Sep 1977
Decision
13d
Days
Class 2
Risk

K771668 is an FDA 510(k) clearance for the DISP. FLUID ISOLATOR & PRESS. RELIEF. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Ailtech (Mchenry, US). The FDA issued a Cleared decision on September 14, 1977 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - the FDA cardiovascular device oversight 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 Ailtech devices

FDA 510(k) Submission Details - K771668

510(k) Number K771668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1977
Decision Date September 14, 1977
Days to Decision 13 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 125d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRS Device Classification - Class 2, Special Controls

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRS Transducer, Blood-pressure, Extravascular

All 105
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K771668.
TRANSDUCER, PRESSURE, OPTION, H-P, P23ID
K780797 · Gould, Inc. · Jun 1978
DINAMAP MODEL 850
K780127 · Applied Medical Research · Jan 1978
BLOOD PRESSURE MONITOR, ARTERIAL
K780128 · Applied Medical Research · Jan 1978
PHYSIOLOGICAL PRESSURE TRANSDUCER 1290A
K771361 · Hewlett-Packard Co. · Aug 1977
MODEL DA-53 PRESSURE GUAGE ISOLATOR
K761325 · Extracorporeal Medical Specialities, Inc. · Jan 1977