Cleared Traditional

FLEX NEEDLE (K961049) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961049 · Lighthouse Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
187d
Days
Class 2
Risk

K961049 is an FDA 510(k) clearance for the FLEX NEEDLE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Lighthouse Medical, Inc. (Waltham, US). The FDA issued a Cleared decision on September 18, 1996 after a review of 187 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Lighthouse Medical, Inc. devices

Submission Details

510(k) Number K961049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1996
Decision Date September 18, 1996
Days to Decision 187 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
58d slower than avg
Panel avg: 129d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 208
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K961049.
INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
K970438 · Baxter Healthcare Corp · Apr 1997
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
K964850 · Baxter Healthcare Corp · Feb 1997
INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE
K962893 · Baxter Healthcare Corp · Oct 1996
FLUID ADMINISTRATION SET - CONTRAST MANAGER
K961794 · Merit Medical Systems, Inc. · Aug 1996
HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE
K961495 · Baxter Healthcare Corp · Jun 1996
CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
K961225 · Baxter Healthcare Corp · Jun 1996