Cleared Traditional

K070143 - JMS PLANECTA STOPCOCK

K070143 is an FDA 510(k) clearance for JMS PLANECTA STOPCOCK, manufactured by Jms North America Corp.. The device is a Class 2 General Hospital device with product code FMG cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K070143 · Jms North America Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
84d
Days
Class 2
Risk

K070143 is an FDA 510(k) clearance for the JMS PLANECTA STOPCOCK. Classified as Stopcock, I.v. Set (product code FMG), Class II - Special Controls.

Submitted by Jms North America Corp. (Hayward, US). The FDA issued a Cleared decision on April 10, 2007 after a review of 84 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. 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 Jms North America Corp. devices

FDA 510(k) Submission Details - K070143

510(k) Number K070143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2007
Decision Date April 10, 2007
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMG Device Classification - Class 2, Special Controls

Product Code FMG Stopcock, I.v. Set
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 - FMG Stopcock, I.v. Set

All 57
Devices cleared under the same product code (FMG) and FDA review panel - the closest regulatory comparables to K070143.
ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS)
K082106 · Elcam Medical Acal · Oct 2008
CLAVE STOPCOCK
K080077 · Icu Medical, Inc. · Feb 2008
SMARTSITE STOPCOCK
K071400 · Cardinal Health, Alaris Products · Dec 2007
BACSTOP
K053405 · Elcam Medical Acal · May 2006
ROBERTSITE STOPCOCK
K061143 · Halkey-Roberts Corp. · May 2006
CLOSED SWABABLE STOPCOCK AND MINIMAL RESIDUAL VOLUME LUER-ACTIVATED SWABABLE-STOPCOCK
K060231 · Elcam Medical Acal · Apr 2006