Cleared Traditional

K771203 - DISP. HYPODERMIC NEEDLE

K771203 is the FDA 510(k) clearance for DISP. HYPODERMIC NEEDLE by Terumo America, Inc.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K771203 · Terumo America, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1977
Decision
9d
Days
Class 2
Risk

K771203 is an FDA 510(k) clearance for the DISP. HYPODERMIC NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Terumo America, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 14, 1977 after a review of 9 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 Terumo America, Inc. devices

Submission Details

510(k) Number K771203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1977
Decision Date July 14, 1977
Days to Decision 9 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 129d · This submission: 9d
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 245
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K771203.
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
TERUFUSION DONOR SET
K771207 · Terumo America, Inc. · Jul 1977
FILTER DEVICES
K761098 · Arrow Intl., Inc. · Jan 1977
DOUBLE-ENDED NEEDLE
K760780 · Travenol Laboratories, S.A. · Nov 1976