Cleared Traditional

STERILE BLOOD ADMINISTRATION SET (K780658) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K780658 · Suru Chemicals & Pharmaceuticals, Ltd. · General Hospital
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Jul 1978
Decision
90d
Days
Class 2
Risk

K780658 is an FDA 510(k) clearance for the STERILE BLOOD ADMINISTRATION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Suru Chemicals & Pharmaceuticals, Ltd. (Mchenry, US). The FDA issued a Cleared decision on July 19, 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 880.5440 - 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 Suru Chemicals & Pharmaceuticals, Ltd. devices

Submission Details

510(k) Number K780658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1978
Decision Date July 19, 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.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 208
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K780658.
SOLUTION ADMINISTRATION, FLEX VALVE
K781812 · Travenol Laboratories, S.A. · Dec 1978
AUTO-SYRINGE INFUSION SET
K781036 · Baxter Healthcare Corp · Aug 1978
BURETTE SET WITH AIR CONTROL LEVER
K780970 · Travenol Laboratories, S.A. · Jul 1978
I.V. LEVER CLAMP
K780481 · Travenol Laboratories, S.A. · Apr 1978
IN-LINE BURETTE SET
K772036 · Abbott Laboratories · Nov 1977
I.V. PUMP SET FOR FAT EMULSION
K771593 · Abbott Laboratories · Sep 1977