Cleared Traditional

K982097 - WORLDWIDE MEDICAL TECHNOLOGIES INTRACER...

K982097 is an FDA 510(k) clearance for WORLDWIDE MEDICAL TECHNOLOGIES INTRACER..., manufactured by Worldwide Medical Technologies, LLC. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K982097 · Worldwide Medical Technologies, LLC · General Hospital
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Jun 1998
Decision
10d
Days
Class 2
Risk

K982097 is an FDA 510(k) clearance for the WORLDWIDE MEDICAL TECHNOLOGIES INTRACERVICAL BLOCK NEEDLE, MODEL TBD. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Worldwide Medical Technologies, LLC (Woodbury, US). The FDA issued a Cleared decision on June 25, 1998 after a review of 10 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 Worldwide Medical Technologies, LLC devices

FDA 510(k) Submission Details - K982097

510(k) Number K982097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1998
Decision Date June 25, 1998
Days to Decision 10 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 129d · This submission: 10d
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 264
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K982097.
K-PACK II (HYPODERMIC NEEDLE) 23G X 1, MODEL KN-2325RB, K-PACK II NEEDLE (HYPODERMIC NEEDLE) 25G X 1, MODEL KN-2525RB, K
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DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
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BLUNT SYRINGE CANNULA
K971924 · B.Braun Medical, Inc. · Sep 1998
BECTON DICKINSON BLUNT PLASTIC CANNULA
K974363 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
RESHEATHER DEVICE-METAL OR PLASTIC, RESHEATER/ NEEDLE HOLDER DEVICE-PLASTIC
K972705 · Sage Products, Inc. · Apr 1998
MANAN GALACTOGRAPHY KIT
K980227 · Medical Device Technologies, Inc. · Apr 1998