Cleared Traditional

K970800 - MAXCESS NEEDLEFREE - Y- SITE (100713)

K970800 is an FDA 510(k) clearance for MAXCESS NEEDLEFREE - Y- SITE (100713), manufactured by Solopak Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K970800 · Solopak Medical Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
29d
Days
Class 2
Risk

K970800 is an FDA 510(k) clearance for the MAXCESS NEEDLEFREE - Y- SITE (100713). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Solopak Medical Products, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 29 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 Solopak Medical Products, Inc. devices

FDA 510(k) Submission Details - K970800

510(k) Number K970800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1997
Decision Date April 02, 1997
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 644
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