Cleared Traditional

K790953 - BORDISPO BRAND HYPODERMIC NEEDLE

K790953 is an FDA 510(k) clearance for BORDISPO BRAND HYPODERMIC NEEDLE, manufactured by Borda Products, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K790953 · Borda Products, Inc. · General Hospital
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Jun 1979
Decision
36d
Days
Class 2
Risk

K790953 is an FDA 510(k) clearance for the BORDISPO BRAND HYPODERMIC NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Borda Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1979 after a review of 36 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 Borda Products, Inc. devices

FDA 510(k) Submission Details - K790953

510(k) Number K790953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1979
Decision Date June 27, 1979
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 531
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K790953.
DOUBLE ENDED FILTERED TRANSFER NEEDLE
K801107 · Burron Medical Products, Inc. · May 1980
DOUBLE ENDED VENTED TRANSFER DEVICE
K801108 · Burron Medical Products, Inc. · May 1980
AMIPAQUE MYELOGRAM TRAY
K791156 · Pharmaseal Div., Baxter Healthcare Corp. · Jul 1979
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