Cleared Traditional

K780086 - INFUSION APPARATUS

K780086 is the FDA 510(k) clearance for INFUSION APPARATUS by Ohio Medical Products. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K780086 · Ohio Medical Products · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1978
Decision
17d
Days
Class 2
Risk

K780086 is an FDA 510(k) clearance for the INFUSION APPARATUS, POWERED. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on January 30, 1978 after a review of 17 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 Ohio Medical Products devices

Submission Details

510(k) Number K780086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1978
Decision Date January 30, 1978
Days to Decision 17 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
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 307
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K780086.
MODEL IV6000 INFUSION PUMP
K790332 · Valleylab, Inc. · Apr 1979
IVAC 630 VOLUMETRIC INFUSION PUMP
K790373 · Y · Apr 1979
INFUSION PUMP, MODEL AS*5
K782034 · Baxter Healthcare Corp · Feb 1979
LIFECARE I.V. PUMP - MODEL III
K772094 · Abbott Laboratories · Dec 1977
I.V. PUMP, ABBOTT/SHAW LIFECARE
K770087 · Abbott Laboratories · Feb 1977
AUTO SYRINGE MODEL AS-3A
K761307 · Baxter Healthcare Corp · Jan 1977