Cleared Traditional

K781297 - INTRA-ALERT

K781297 is an FDA 510(k) clearance for INTRA-ALERT, manufactured by Pan-Tech Research, Inc.. The device is a Class 2 General Hospital device with product code FLN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K781297 · Pan-Tech Research, Inc. · General Hospital
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Oct 1978
Decision
90d
Days
Class 2
Risk

K781297 is an FDA 510(k) clearance for the INTRA-ALERT. Classified as Monitor, Electric For Gravity Flow Infusion Systems (product code FLN), Class II - Special Controls.

Submitted by Pan-Tech Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 25, 1978 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2420 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Pan-Tech Research, Inc. devices

FDA 510(k) Submission Details - K781297

510(k) Number K781297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1978
Decision Date October 25, 1978
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLN Device Classification - Class 2, Special Controls

Product Code FLN Monitor, Electric For Gravity Flow Infusion Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.2420
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 General Hospital devices follow this clearance model.

Regulatory Peers - FLN Monitor, Electric For Gravity Flow Infusion Systems

All 22
Devices cleared under the same product code (FLN) and FDA review panel - the closest regulatory comparables to K781297.
IMED DROP RATE CALCULATOR #340
K801734 · Imed Corp. · Oct 1980
DROP CONTROLLER
K790669 · Imed Corp. · May 1979
VOLUMETRIC CONTROLLER MODEL 310
K781589 · Imed Corp. · Nov 1978
PARENTERAL INFUSION CONTROLLER
K780223 · Travenol Laboratories, S.A. · Apr 1978
PARENTERAL INFUSION CONTROLLER, ELEC.
K780106 · National Patent Development Corp. · Feb 1978