Cleared Traditional

K961049 - FLEX NEEDLE

K961049 is an FDA 510(k) clearance for FLEX NEEDLE, manufactured by Lighthouse Medical, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 187-day FDA review.

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

FDA 510(k) Submission Details - K961049

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.

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 514
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K961049.
POLYFIN QR WITH WINGS INFUSION SETS, MODELS 365, 366, AND 367
K964456 · Medtronic Minimed · Jan 1997
INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE
K962893 · Baxter Healthcare Corp · Oct 1996
DELTEC SUBCUTANEOUS INFUSION SET
K963009 · Sims Deltec, Inc. · 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