Cleared Traditional

K771825 - CARBA LINGUARDUC

K771825 is an FDA 510(k) clearance for CARBA LINGUARDUC, manufactured by C.R. Bard, Inc.. The device is a Class 2 Physical Medicine device with product code ILQ cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K771825 · C.R. Bard, Inc. · Physical Medicine device
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Oct 1977
Decision
9d
Days
Class 2
Risk

K771825 is an FDA 510(k) clearance for the CARBA LINGUARDUC. Classified as System, Communication, Powered (product code ILQ), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1977 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3710 - the FDA physical medicine 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.

FDA 510(k) Submission Details - K771825

510(k) Number K771825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1977
Decision Date October 06, 1977
Days to Decision 9 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d faster than avg
Panel avg: 116d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILQ Device Classification - Class 2, Special Controls

Product Code ILQ System, Communication, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3710
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - ILQ System, Communication, Powered

All 37
Devices cleared under the same product code (ILQ) and FDA review panel - the closest regulatory comparables to K771825.
THE COMMUNICATOR
K821677 · Robert Swinney. , Ltd. · Jun 1982
BODAI PATIENT COMMUNICATOR
K812720 · Sontek Industries, Inc. · Nov 1981
SPEAKEASY COMMUN. SYSTEM-COMM. PROTHESIS
K802687 · Intelligent Software Systems, Inc. · Feb 1981
TYPEWRITER CONTROL SYSTEMS
K770029 · Possum, Inc. · Jan 1977
ALARM, COMMUN.-SEC. INDEP.-EMER.
K770030 · Possum, Inc. · Jan 1977
ALARM INTERCOM DOOR LOCK
K770031 · Possum, Inc. · Jan 1977
K771825 · CARBA LINGUARDUC
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