Cleared Special

K033099 - ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109

K033099 is an FDA 510(k) clearance for ADR THINSET INFUSION SET MODEL, manufactured by Applied Diabetes Research, Incorporated. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 17-day FDA review.

K033099 · Applied Diabetes Research, Incorporated · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
17d
Days
Class 2
Risk

K033099 is an FDA 510(k) clearance for the ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Applied Diabetes Research, Incorporated (Laguna Niguel, US). The FDA issued a Cleared decision on October 16, 2003 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 880.5440 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033099

510(k) Number K033099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date October 16, 2003
Days to Decision 17 days
Submission Type Special
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
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

FPA Device Classification - Class 2, Special Controls

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 1169
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K033099.
MPS ACACIA SAFEGUARD HUBER DEVICE
K032934 · Mps Acacia · Nov 2003
MEDTRONIC MINIMED PARADIGM COUNTACH INFUSION SET, MODEL MMT 310
K032484 · Medtronic Minimed · Oct 2003
MEDTRONIC MINIMED COUNTACH INFUSION SET, MODEL 313
K032485 · Medtronic Minimed · Oct 2003
UNOMEDICAL MONICA INFUSION SET
K032854 · Unomedical A/S · Oct 2003
SAFETY-MULTIFLY
K032150 · Sarstedt, Inc. · Sep 2003
MARQUETTE HUBER TRAP SAFETY INFUSION SET
K021471 · Marquette Medical, Inc. · Sep 2003
K033099 · ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109
Download PDF FDA Summary Applied Diabetes Rese…