Cleared Traditional

K780209 - DILUTION SPIKE

K780209 is the FDA 510(k) clearance for DILUTION SPIKE by Sterling Drug, Inc.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K780209 · Sterling Drug, Inc. · General Hospital
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Apr 1978
Decision
63d
Days
Class 2
Risk

K780209 is an FDA 510(k) clearance for the DILUTION SPIKE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Sterling Drug, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1978 after a review of 63 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 Sterling Drug, Inc. devices

Submission Details

510(k) Number K780209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1978
Decision Date April 10, 1978
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 249
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K780209.
DOUBLE ENDED FILTERED TRANSFER NEEDLE
K801107 · Burron Medical Products, Inc. · May 1980
DOUBLE ENDED VENTED TRANSFER DEVICE
K801108 · Burron Medical Products, Inc. · May 1980
NEEDLE, TRUCARE VACUTAINER
K790086 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1979
BLOOD GAS TRAY #4024
K771667 · Concord Laboratories, Inc. · Oct 1977
TERUFUSION BLOOD ADMIN. SET
K771209 · Terumo America, Inc. · Jul 1977
DISP. HYPODERMIC NEEDLE
K771203 · Terumo America, Inc. · Jul 1977