Cleared Traditional

K921050 - ULTRAFLO RATESAVER PLUS INFUSION PUMP

K921050 is an FDA 510(k) clearance for ULTRAFLO RATESAVER PLUS INFUSION PUMP, manufactured by Clinical Systems, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 516-day FDA review.

K921050 · Clinical Systems, Inc. · General Hospital
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Aug 1993
Decision
516d
Days
Class 2
Risk

K921050 is an FDA 510(k) clearance for the ULTRAFLO RATESAVER PLUS INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Clinical Systems, Inc. (Great Neck, US). The FDA issued a Cleared decision on August 3, 1993 after a review of 516 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Clinical Systems, Inc. devices

FDA 510(k) Submission Details - K921050

510(k) Number K921050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1992
Decision Date August 03, 1993
Days to Decision 516 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
387d slower than avg
Panel avg: 129d · This submission: 516d
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 613
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K921050.
ABBOTT PLUM XL INFUSION PUMP
K931375 · Abbott Laboratories · Sep 1993
CADD-MICRO(TM) MODEL 5900 AMBULATORY INFUSION PUMP
K931132 · Pharmacia Deltec, Inc. · Aug 1993
INFUSION PUMP
K930781 · Y · Aug 1993
IVAC SYRING PUMP MODEL 770
K925091 · Y · Jul 1993
MODEL 880 INFUSION PUMP, MODIFICATION
K924871 · 3M Health Care, Ltd. · Jun 1993
BIO CLINIC UNDER PATIENT SCALE
K925112 · Sunrise Medical, Inc. · Jun 1993