Cleared Traditional

K781216 - INFUSION CONTROLLER

K781216 is an FDA 510(k) clearance for INFUSION CONTROLLER, manufactured by National Patent Development Corp.. The device is a Class 2 Anesthesiology device with product code FLS cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K781216 · National Patent Development Corp. · Anesthesiology device
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Aug 1978
Decision
24d
Days
Class 2
Risk

K781216 is an FDA 510(k) clearance for the INFUSION CONTROLLER, PARENTERAL. Classified as Monitor, Apnea, Facility Use (product code FLS), Class II - Special Controls.

Submitted by National Patent Development Corp. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2377 - 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 National Patent Development Corp. devices

FDA 510(k) Submission Details - K781216

510(k) Number K781216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1978
Decision Date August 10, 1978
Days to Decision 24 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 140d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLS Device Classification - Class 2, Special Controls

Product Code FLS Monitor, Apnea, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2377
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.