Cleared Special

K100282 - TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER

K100282 is an FDA 510(k) clearance for TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER, manufactured by Terumo Corp.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Special 510(k) pathway after a 25-day FDA review.

K100282 · Terumo Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
25d
Days
Class 2
Risk

K100282 is an FDA 510(k) clearance for the TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Terumo Corp. (Elkton, US). The FDA issued a Cleared decision on February 26, 2010 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 - K100282

510(k) Number K100282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2010
Decision Date February 26, 2010
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 495
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K100282.
BD NEXIVA CLOSED IV CATHETER SYSTEM
K102520 · Becton Dickinson Infusion Therapy Systems, Inc. · Jan 2011
BD INTIMA II CLOSED IV CATHETER
K100775 · Becton Dickinson Infusion Therapy Systems, Inc. · Jun 2010
SPECTRUM TURBO-JECT PICC SET
K100974 · Cook Incorporated · May 2010
SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX
K093546 · Togo Medikit Co., Ltd. · Dec 2009
MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC
K091709 · Edwards Lifesciences, LLC · Oct 2009
SNM FIRMGRIP
K092629 · Flexicath , Ltd. · Sep 2009
K100282 · TERUMO SURSHIELD- PUR SAFETY I.V. CATHETER
Download PDF FDA Summary Terumo Corp.