Cleared Traditional

K926071 - ONCO-VIAL ADAPTER

K926071 is an FDA 510(k) clearance for ONCO-VIAL ADAPTER, manufactured by David Bull Laboratories, USA, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 440-day FDA review.

K926071 · David Bull Laboratories, USA, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
440d
Days
Class 2
Risk

K926071 is an FDA 510(k) clearance for the ONCO-VIAL ADAPTER. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by David Bull Laboratories, USA, Inc. (Scottsdale, US). The FDA issued a Cleared decision on February 14, 1994 after a review of 440 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all David Bull Laboratories, USA, Inc. devices

FDA 510(k) Submission Details - K926071

510(k) Number K926071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date February 14, 1994
Days to Decision 440 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
311d slower than avg
Panel avg: 129d · This submission: 440d
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 150
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K926071.
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