Cleared Traditional

K780503 - INFUSION PUMP

K780503 is an FDA 510(k) clearance for INFUSION PUMP, manufactured by Air-Shields, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K780503 · Air-Shields, Inc. · General Hospital
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Apr 1978
Decision
12d
Days
Class 2
Risk

K780503 is an FDA 510(k) clearance for the INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Air-Shields, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1978 after a review of 12 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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: 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 Air-Shields, Inc. devices

FDA 510(k) Submission Details - K780503

510(k) Number K780503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1978
Decision Date April 10, 1978
Days to Decision 12 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 129d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 454
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K780503.
IVAC 630 VOLUMETRIC INFUSION PUMP
K790373 · Y · Apr 1979
INFUSION PUMP, MODEL AS*5
K782034 · Baxter Healthcare Corp · Feb 1979
INFUSION PUMP, PEDIATRIC MODEL 301
K781171 · Imed Corp. · Aug 1978
INFUSION APPARATUS, POWERED
K780086 · Ohio Medical Products · Jan 1978
LIFECARE I.V. PUMP - MODEL III
K772094 · Abbott Laboratories · Dec 1977
VOLUMETRIC INFUSION PUMP MODEL 960
K771664 · Imed Corp. · Sep 1977