Cleared Traditional

K072625 - TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC)

K072625 is an FDA 510(k) clearance for TURBO-JECT PERIPHERALLY INSERTED CENTRA..., manufactured by Cook, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K072625 · Cook, Inc. · General Hospital
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Dec 2007
Decision
87d
Days
Class 2
Risk

K072625 is an FDA 510(k) clearance for the TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC). Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 13, 2007 after a review of 87 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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 Cook, Inc. devices

FDA 510(k) Submission Details - K072625

510(k) Number K072625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2007
Decision Date December 13, 2007
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 257
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K072625.
PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)
K081904 · Medcomp · Sep 2008
PRESSURE INJFECTABLE PICC
K080604 · Arrow International, Inc. · Jun 2008
PRESSURE INJECTABLE PICC
K073451 · Arrow International, Inc. · Jan 2008
PRO-PICC, BASIC TRAY
K072509 · Medcomp · Nov 2007
PFM PICC
K072391 · Pfm Medical, Inc. · Nov 2007
V-CATH POLY PICC
K071875 · Hdc Corp. · Nov 2007