Cleared Traditional

K760103 - CAP, INJECTION (#4600)

K760103 is an FDA 510(k) clearance for CAP, manufactured by Jelco Laboratories. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K760103 · Jelco Laboratories · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1976
Decision
23d
Days
Class 2
Risk

K760103 is an FDA 510(k) clearance for the CAP, INJECTION (#4600). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Jelco Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 16, 1976 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Jelco Laboratories devices

FDA 510(k) Submission Details - K760103

510(k) Number K760103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1976
Decision Date July 16, 1976
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 657
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K760103.
ERIKA I.V. ADMINISTRATION SET
K770171 · Erika, Inc. · Mar 1977
VENOSET FOR I.V. FAT EMULSION
K770051 · Abbott Laboratories · Feb 1977
IV SETS 2000 SERIES (HS-200,2L0,220)
K761327 · Extracorporeal Medical Specialities, Inc. · Jan 1977
FILTER, I.V. (#4700)
K760110 · Jelco Laboratories · Jul 1976
FILTER, I.V., WITH FLASH BULB (#4701)
K760111 · Jelco Laboratories · Jul 1976