Cleared Traditional

K071741 - TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

K071741 is an FDA 510(k) clearance for TEVADAPTOR, manufactured by Migada Plant. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K071741 · Migada Plant · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
89d
Days
Class 2
Risk

K071741 is an FDA 510(k) clearance for the TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Migada Plant (Kiryat Shmona, IL). The FDA issued a Cleared decision on September 24, 2007 after a review of 89 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 - K071741

510(k) Number K071741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2007
Decision Date September 24, 2007
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
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 189
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K071741.
SMART-ROD
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SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD
K052790 · Cardinal Health, Alaris Products · Dec 2005
K071741 · TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
Download PDF FDA Summary Migada Plant