Cleared Traditional

K812233 - RATEMINDER

K812233 is an FDA 510(k) clearance for RATEMINDER, manufactured by Anatros Corp.. The device is a Class 2 General Hospital device with product code LDR cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K812233 · Anatros Corp. · General Hospital
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Aug 1981
Decision
14d
Days
Class 2
Risk

K812233 is an FDA 510(k) clearance for the RATEMINDER. Classified as Controller, Infusion, Intravascular, Electronic (product code LDR), Class II - Special Controls.

Submitted by Anatros Corp. (Mchenry, US). The FDA issued a Cleared decision on August 25, 1981 after a review of 14 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 Anatros Corp. devices

FDA 510(k) Submission Details - K812233

510(k) Number K812233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1981
Decision Date August 25, 1981
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDR Device Classification - Class 2, Special Controls

Product Code LDR Controller, Infusion, Intravascular, Electronic
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 - LDR Controller, Infusion, Intravascular, Electronic

All 33
Devices cleared under the same product code (LDR) and FDA review panel - the closest regulatory comparables to K812233.
380 PIGGYBACK CONTROLLER
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SKIN SCRUB-TRAY
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TRAVENOL INFUSION CONTROLLER 2M8052
K812510 · Travenol Laboratories, S.A. · Sep 1981
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K812114 · Abbott Laboratories · Aug 1981
MILLIPORE DUAL RATE INTRAVENOUS CASSETTE
K811432 · Millipore Corp. · Jul 1981
IVAC 260 SERIES VOLUME TRIC INFUSION CON
K801861 · Y · Aug 1980