Cleared Traditional

K003730 - CHEMO-AIDE DISPENSING PIN

K003730 is an FDA 510(k) clearance for CHEMO-AIDE DISPENSING PIN, manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K003730 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2000
Decision
16d
Days
Class 2
Risk

K003730 is an FDA 510(k) clearance for the CHEMO-AIDE DISPENSING PIN. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on December 20, 2000 after a review of 16 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.

FDA 510(k) Submission Details - K003730

510(k) Number K003730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2000
Decision Date December 20, 2000
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
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 206
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K003730.
INTER-VIAL
K010703 · Duoject Medical Systems, Inc. · Jun 2001
RECONSTITUTION KIT & VIAL CONNECTOR
K010623 · Bioject, Inc. · Apr 2001
EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
K002705 · Baxa Corp. · Mar 2001
NEEDLELESS TRANSFER DEVICE
K001831 · Medimop Medical Projects, Ltd. · Jul 2000
PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER
K001368 · Carmel Pharma Ab. · May 2000
MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE
K001293 · Medimop Medical Projects, Ltd. · May 2000
K003730 · CHEMO-AIDE DISPENSING PIN
Download PDF FDA Summary Baxter Healthcare Corp