Cleared Traditional

K892906 - 60 MICROBORE EXTENSION SET W/ANTI-SIPHO...

K892906 is the FDA 510(k) clearance for 60 MICROBORE EXTENSION SET W/ANTI-SIPHO... by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K892906 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Jul 1989
Decision
96d
Days
Class 2
Risk

K892906 is an FDA 510(k) clearance for the 60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on July 25, 1989 after a review of 96 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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. Standard predicate reliance. 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K892906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1989
Decision Date July 25, 1989
Days to Decision 96 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 129d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 449
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K892906.
IVAC(R) SPACE.SAVER(TM) VOLUMETRIC PUMP MODEL 599
K894037 · Y · Aug 1989
LIFECARE MICRO PUMP
K883645 · Abbott Laboratories · Aug 1989
IVSK09 CALIBRATION KIT AN ACCESSORY TO IV7000/7200
K890786 · Valleylab, Inc. · Jul 1989
BASAL/BOLUS INFUSORS
K884505 · Baxter Healthcare Corp · Jul 1989
IVAC VARIABLE PRESSURE VOLUMETRIC PUMP, 570 SERIES
K891583 · Y · Jun 1989
RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP
K890282 · Abbott Laboratories · Apr 1989