Cleared Traditional

K042121 - SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY

K042121 is an FDA 510(k) clearance for SPECTRUM AND SPECTRUM WITH MASTER DRUG ..., manufactured by Sigma Intl.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K042121 · Sigma Intl. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
20d
Days
Class 2
Risk

K042121 is an FDA 510(k) clearance for the SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Sigma Intl. (Medina, US). The FDA issued a Cleared decision on August 26, 2004 after a review of 20 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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.

FDA 510(k) Submission Details - K042121

510(k) Number K042121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2004
Decision Date August 26, 2004
Days to Decision 20 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 Consultant

Intertek Testing Services
DERWYN REUBER

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRN Pump, Infusion

All 841
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K042121.
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K042609 · Hospira, Inc. · Oct 2004
E-PAIN CARE
K041714 · Breg, Inc. · Oct 2004
CRONO F
K042085 · Cane S.R.L. · Sep 2004
PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K042081 · Hospira, Inc. · Aug 2004
BAXTER INFUSOR SV (SMALL VOLUME)
K041738 · Baxter Healthcare Corporation · Jul 2004
CRONO AND CRONO, MODEL 30
K041414 · Cane S.R.L. · Jul 2004

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K042121 · SPECTRUM AND SPECTRUM WITH MASTER DRUG LIBRARY
Download PDF FDA Summary Sigma Intl.