Cleared Traditional

K001604 - DANA DIABECARE

K001604 is an FDA 510(k) clearance for DANA DIABECARE, manufactured by Sooil Development Co., Ltd.. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K001604 · Sooil Development Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
82d
Days
Class 2
Risk

K001604 is an FDA 510(k) clearance for the DANA DIABECARE. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Sooil Development Co., Ltd. (North Attleboro, US). The FDA issued a Cleared decision on August 14, 2000 after a review of 82 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 Sooil Development Co., Ltd. devices

FDA 510(k) Submission Details - K001604

510(k) Number K001604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2000
Decision Date August 14, 2000
Days to Decision 82 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 129d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZG Device Classification - Class 2, Special Controls

Product Code LZG Pump, Infusion, Insulin
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 - LZG Pump, Infusion, Insulin

All 51
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K001604.
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
K031738 · Smiths Medical MD, Inc. · May 2004
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
K040676 · Medtronic Minimed · May 2004
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164 · Medtronic Minimed · Oct 2003
R1000 SERIES INSULIN PUMP
K993184 · Animas Corp. · Feb 2000
DISETRONIC D-TRON INSULIN INFUSION PUMP
K994186 · Disetronic Medical Systems · Dec 1999
MINIMED COM-STATION, HARDWARE-7301
K993012 · Medtronic Minimed · Nov 1999