Cleared Traditional

K913891 - DISETRONIC(R) INFUSOR

K913891 is an FDA 510(k) clearance for DISETRONIC INFUSOR, manufactured by Disetronic Medical Systems. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K913891 · Disetronic Medical Systems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
210d
Days
Class 2
Risk

K913891 is an FDA 510(k) clearance for the DISETRONIC(R) INFUSOR. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Disetronic Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on March 27, 1992 after a review of 210 days - an extended review 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: 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 Disetronic Medical Systems devices

FDA 510(k) Submission Details - K913891

510(k) Number K913891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1991
Decision Date March 27, 1992
Days to Decision 210 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 129d · This submission: 210d
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 523
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K913891.
AVI MODEL 3000 INFUSION PUMP
K920588 · 3M Health Care, Ltd. · Apr 1992
AVI MODEL 275CI INFUSION PUMP
K920680 · 3M Health Care, Ltd. · Apr 1992
AVI MODEL 285CI INFUSION PUMP
K920681 · 3M Health Care, Ltd. · Apr 1992
FLO-GARD 8000 HALF-SET
K915499 · Baxter Healthcare Corp · Mar 1992
PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF
K913931 · Abbott Laboratories · Mar 1992
FLO-GARD(R) 6201
K915522 · Baxter Healthcare Corp · Feb 1992