Cleared Traditional

K972135 - MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET

K972135 is an FDA 510(k) clearance for MAERSK MEDICAL PURELINE COMFORT SUBCUTA..., manufactured by P/L Biomedical. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K972135 · P/L Biomedical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
81d
Days
Class 2
Risk

K972135 is an FDA 510(k) clearance for the MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by P/L Biomedical (Fort Myers, US). The FDA issued a Cleared decision on August 26, 1997 after a review of 81 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 P/L Biomedical devices

FDA 510(k) Submission Details - K972135

510(k) Number K972135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1997
Decision Date August 26, 1997
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
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 603
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K972135.
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K970855 · Icu Medical, Inc. · Jun 1997