Cleared Traditional

K923782 - TRANSFER SET

K923782 is an FDA 510(k) clearance for TRANSFER SET, manufactured by Pacific Device, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K923782 · Pacific Device, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
339d
Days
Class 2
Risk

K923782 is an FDA 510(k) clearance for the TRANSFER SET. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Pacific Device, Inc. (San Diego, US). The FDA issued a Cleared decision on July 2, 1993 after a review of 339 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

View all Pacific Device, Inc. devices

FDA 510(k) Submission Details - K923782

510(k) Number K923782 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date July 02, 1993
Days to Decision 339 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
210d slower than avg
Panel avg: 129d · This submission: 339d
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 95
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K923782.
DISPENSING PIN WITH ONE-WAY VALVE
K943181 · B. Braun of America, Inc. · Sep 1994
TRANSFER SET
K935532 · Puritas Health Care, Inc. · Apr 1994
DIPRIVAN LUER CONNECTOR
K935274 · Ohmeda Medical · Mar 1994
INTERLINK UNIVERSAL VIAL ADAPTER
K924064 · Baxter Healthcare Corp · Apr 1993
IV FLUID TRANSFER PIN
K925401 · B. Braun of America, Inc. · Mar 1993
NUTRIMIX MICROCOMPOUNDER
K921365 · Abbott Laboratories · Jun 1992