Cleared Traditional

K010188 - BD ECLIPSE HYPODERMIC NEEDLE

K010188 is an FDA 510(k) clearance for BD ECLIPSE HYPODERMIC NEEDLE, manufactured by Bd Medical Systems. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K010188 · Bd Medical Systems · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
38d
Days
Class 2
Risk

K010188 is an FDA 510(k) clearance for the BD ECLIPSE HYPODERMIC NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Bd Medical Systems (Franklin Lakes, US). The FDA issued a Cleared decision on March 1, 2001 after a review of 38 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.

FDA 510(k) Submission Details - K010188

510(k) Number K010188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2001
Decision Date March 01, 2001
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 692
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K010188.
SHIELDING NEEDLE HOLDER
K003381 · U.S. Safety Syringes Co., Inc. · Apr 2001
DISPO-MED 7.6 LITER SHARPS CONTAINER
K003521 · Master Benefits, Inc. · Apr 2001
SARSTEDT NEEDLE PROTECTOR
K003382 · Sarstedt, Inc. · Mar 2001
EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
K003627 · Exelint International, Co. · Feb 2001
SAFE-POINT VAC, SAFE-POINT M-D BLOOD COLLECTION SYSTEMS
K001965 · North American Medical Products, Inc. · Feb 2001
BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE
K003461 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 2001
K010188 · BD ECLIPSE HYPODERMIC NEEDLE
Download PDF FDA Summary Bd Medical Systems