Cleared Traditional

K943952 - DISETRONIC D-MODEM

K943952 is an FDA 510(k) clearance for DISETRONIC D-MODEM, 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 418-day FDA review.

K943952 · Disetronic Medical Systems · General Hospital
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Oct 1995
Decision
418d
Days
Class 2
Risk

K943952 is an FDA 510(k) clearance for the DISETRONIC D-MODEM. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Disetronic Medical Systems (Minneapolis, US). The FDA issued a Cleared decision on October 7, 1995 after a review of 418 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Disetronic Medical Systems devices

FDA 510(k) Submission Details - K943952

510(k) Number K943952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received August 15, 1994
Decision Date October 07, 1995
Days to Decision 418 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
289d slower than avg
Panel avg: 129d · This submission: 418d
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 K943952.
SMARTDOSE IV PREFILLED INFUSION CONTAINER
K944351 · River Medical, Inc. · Nov 1995
SMARTDOSE III INFUSION CONTAINER
K944352 · River Medical, Inc. · Nov 1995
PLUM XL INFUSION PUMP (MODIFICATION)
K953660 · Abbott Laboratories · Oct 1995
ADI SYSTEM
K933825 · Abbott Laboratories · Sep 1995
AUTO SYRINGE(R) AS50 INFUSION PUMP
K945942 · Baxter Healthcare Corp · Jul 1995
THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
K950419 · Imed Corp. · Jun 1995