Cleared Traditional

K841018 - PANCRETEC PUMP CHECK

K841018 is an FDA 510(k) clearance for PANCRETEC PUMP CHECK, manufactured by Pancretec, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K841018 · Pancretec, Inc. · General Hospital
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Apr 1984
Decision
27d
Days
Class 2
Risk

K841018 is an FDA 510(k) clearance for the PANCRETEC PUMP CHECK. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Pancretec, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 5, 1984 after a review of 27 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 Pancretec, Inc. devices

FDA 510(k) Submission Details - K841018

510(k) Number K841018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1984
Decision Date April 05, 1984
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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 619
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K841018.
ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232
K841922 · American Edwards Laboratories · Jul 1984
FLEXIFLO-III PORTABLE ENTERAL NUTRI
K841784 · Abbott Laboratories · Jun 1984
ETHOX RELIA-FLO 2001 ENTERAL FEED
K841512 · Ethox Corp. · May 1984
INFUSION PUMP
K832470 · Delta Medical Industries · Feb 1984
LIFECARE 4/HOMECARE - 4H PUMP
K840263 · Abbott Laboratories · Feb 1984
GILLETTE SABRE SYRINGE
K833655 · Intermedics, Inc. · Dec 1983