Cleared Traditional

K980381 - PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO

K980381 is an FDA 510(k) clearance for PHASEAL, manufactured by Carmel Pharma Ab.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K980381 · Carmel Pharma Ab. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
29d
Days
Class 2
Risk

K980381 is an FDA 510(k) clearance for the PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRA.... Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Carmel Pharma Ab. (Gothenburg, SE). The FDA issued a Cleared decision on March 3, 1998 after a review of 29 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 - K980381

510(k) Number K980381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1998
Decision Date March 03, 1998
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 K980381.
CODAN CHEMOSPIKE
K990711 · Codan US Corp. · Apr 1999
CHEMO MINI SPIKE PLUS
K983794 · B. Braun of America, Inc. · Mar 1999
IV DECANTER-FLEXIBLE
K980587 · Inrad · Apr 1998
CHEMO-SPIKE II RECONSTITUTION DEVICE
K974431 · Medi-Dose, Inc. · Jan 1998
TAKY-SPIKE PLUS
K974198 · Clinico · Dec 1997
VIAL-MATE RECONSTITUTION DEVICE (2B8071)
K973654 · Baxter Healthcare Corp · Oct 1997
K980381 · PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO
Download PDF FDA Summary Carmel Pharma Ab.