Cleared Traditional

K895630 - B-D PEND NEEDLE

K895630 is an FDA 510(k) clearance for B-D PEND NEEDLE, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K895630 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Dec 1989
Decision
80d
Days
Class 2
Risk

K895630 is an FDA 510(k) clearance for the B-D PEND NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on December 8, 1989 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K895630

510(k) Number K895630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1989
Decision Date December 08, 1989
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 494
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K895630.
SAFETY NEEDLE SHEATH
K904198 · Concord/Portex · Dec 1990
EXEL HUBER NEEDLE
K895769 · Exel Intl. · Feb 1990
EXEL SPINAL NEEDLES
K895771 · Exel Intl. · Feb 1990
SURECUT BMB BONE MARROW BIOPSY/ASPIRATION NEEDLE
K890926 · Meadox Surgimed, Inc. · Jun 1989
STRAIGHT AND RIGHT ANGLE NON-CORING NEEDLES
K884211 · Marquette Medical, Inc. · Oct 1988
WINGED NON-CORING NEEDLE SET
K884212 · Marquette Medical, Inc. · Oct 1988