Cleared Traditional

MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE (K880740) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880740 · Spectramed, Inc. · General Hospital
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Mar 1988
Decision
27d
Days
Class 2
Risk

K880740 is an FDA 510(k) clearance for the MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE. Classified as Actuator, Syringe, Injector Type (product code DQF), Class II - Special Controls.

Submitted by Spectramed, Inc. (Oxnard, US). The FDA issued a Cleared decision on March 22, 1988 after a review of 27 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 870.1670 - 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 Spectramed, Inc. devices

Submission Details

510(k) Number K880740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1988
Decision Date March 22, 1988
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQF Actuator, Syringe, Injector Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1670
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.