Cleared Traditional

K992145 - ECOMED SCALP VEIN SET

K992145 is an FDA 510(k) clearance for ECOMED SCALP VEIN SET, manufactured by Greiner Meditech, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K992145 · Greiner Meditech, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
112d
Days
Class 2
Risk

K992145 is an FDA 510(k) clearance for the ECOMED SCALP VEIN SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Greiner Meditech, Inc. (Bel Air, US). The FDA issued a Cleared decision on October 14, 1999 after a review of 112 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K992145

510(k) Number K992145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 1999
Decision Date October 14, 1999
Days to Decision 112 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
17d faster than avg
Panel avg: 129d · This submission: 112d
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 1017
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K992145.
SHELLY PROTECTED AV FISTULA NEEDLE
K993187 · Diasol, Inc. · Nov 1999
DECAP
K993147 · The Kipp Group · Nov 1999
IV ADMINISTRATION SET
K992266 · New Alliance of Independent Medical Distributors, · Oct 1999
BOLUS ACCESSORY SET
K992072 · I-Flow Corp. · Sep 1999
NAC PRN NEEDLELESS ACCESS CONNECTOR
K992268 · The Kipp Group · Sep 1999
SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321
K991979 · Medtronic Minimed · Sep 1999
K992145 · ECOMED SCALP VEIN SET
Download PDF FDA Summary Greiner Meditech, Inc.