Cleared Traditional

K041232 - GETTIG UNIVERSAL VIAL ACCESS PIN

K041232 is an FDA 510(k) clearance for GETTIG UNIVERSAL VIAL ACCESS PIN, manufactured by Gettig Pharmaceutical Instrument Co.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K041232 · Gettig Pharmaceutical Instrument Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
73d
Days
Class 2
Risk

K041232 is an FDA 510(k) clearance for the GETTIG UNIVERSAL VIAL ACCESS PIN. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Gettig Pharmaceutical Instrument Co. (Spring Mills, US). The FDA issued a Cleared decision on July 22, 2004 after a review of 73 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 Gettig Pharmaceutical Instrument Co. devices

FDA 510(k) Submission Details - K041232

510(k) Number K041232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2004
Decision Date July 22, 2004
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
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 - LHI Set, I.v. Fluid Transfer

All 75
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K041232.
ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE
K090905 · B.Braun Medical, Inc. · Apr 2009
PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET
K041222 · B.Braun Medical, Inc. · Oct 2004
BAXJECT II
K042410 · Baxter Healthcare Corp · Oct 2004
CHEMO DISPENSING PIN, MODEL 12495
K024239 · Abbott Laboratories · Jan 2003
CHEMO-AIDE DISPENSING PIN
K003730 · Baxter Healthcare Corp · Dec 2000
VIAL-MATE RECONSTITUTION DEVICE (2B8071)
K973654 · Baxter Healthcare Corp · Oct 1997