Cleared Traditional

K882025 - MODIFIED EXTRAVAKIT

K882025 is an FDA 510(k) clearance for MODIFIED EXTRAVAKIT, manufactured by Extravakit, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K882025 · Extravakit, Inc. · General Hospital
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Jul 1988
Decision
71d
Days
Class 2
Risk

K882025 is an FDA 510(k) clearance for the MODIFIED EXTRAVAKIT. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Extravakit, Inc. (Tucson, US). The FDA issued a Cleared decision on July 27, 1988 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Extravakit, Inc. devices

FDA 510(k) Submission Details - K882025

510(k) Number K882025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received May 17, 1988
Decision Date July 27, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 543
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K882025.
OPHTHALMIC PAO VALVE
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BD MICROFINE IV PEN INJECTOR
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MX350 (SERIES) CONTROL SYRINGE
K883094 · Medex, Inc. · Aug 1988
HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON.
K880963 · Buckman Co., Inc. · Jun 1988
DISPOSABLE SYRINGE
K882335 · Baxter Healthcare Corp · Jun 1988
MEDSURG MYELOGRAM TRAY
K880693 · Medsurg Industries, Inc. · May 1988