Cleared Traditional

K002138 - PARADIGM SILHOUETTE

K002138 is an FDA 510(k) clearance for PARADIGM SILHOUETTE, manufactured by Maersk Medical A/S. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K002138 · Maersk Medical A/S · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
43d
Days
Class 2
Risk

K002138 is an FDA 510(k) clearance for the PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Maersk Medical A/S (Sylmar, US). The FDA issued a Cleared decision on August 29, 2000 after a review of 43 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 Maersk Medical A/S devices

FDA 510(k) Submission Details - K002138

510(k) Number K002138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2000
Decision Date August 29, 2000
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
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 513
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K002138.
SIMPLICITY WITH WINGS INFUSION SET, (MODEL MMT-103)
K003283 · Sterling Medivations, Inc. · Dec 2000
SIMPLICITY SOFT INFUSION SET
K002492 · Sterling Medivations, Inc. · Oct 2000
SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE
K003225 · Baxter Healthcare Corp · Oct 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · Abbott Laboratories · Aug 2000
POSI-LINK
K000472 · Icu Medical, Inc. · May 2000
CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090
K000942 · Sims Deltec, Inc. · Apr 2000