Cleared Traditional

K941984 - SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP

K941984 is an FDA 510(k) clearance for SABRATEK 6060 HOMERUN VOLUMETRIC INFUSI..., manufactured by Sabratek Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K941984 · Sabratek Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
85d
Days
Class 2
Risk

K941984 is an FDA 510(k) clearance for the SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Sabratek Corp. (Chicago, US). The FDA issued a Cleared decision on July 19, 1994 after a review of 85 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.

View all Sabratek Corp. devices

FDA 510(k) Submission Details - K941984

510(k) Number K941984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1994
Decision Date July 19, 1994
Days to Decision 85 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - FRN Pump, Infusion

All 531
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K941984.
PLUM XL INFUSION PUMP
K944733 · Abbott Laboratories · Feb 1995
ABBOTT LTE INFUSION PUMP
K944125 · Abbott Laboratories · Dec 1994
LOCKBOX
K942161 · Pharmacia Deltec, Inc. · Aug 1994
PROVIDER ANNE INFUSER
K922702 · Abbott Laboratories · Jul 1994
CORPAK ENTERAL PUMP
K932847 · Corpak Co. · Jun 1994
BARD APII PUMP
K926385 · C.R. Bard, Inc. · Apr 1994