Cleared Traditional

K822761 - DELIVERY TUBE SET #2226

K822761 is an FDA 510(k) clearance for DELIVERY TUBE SET #2226, manufactured by Delta Medical Industries. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K822761 · Delta Medical Industries · General Hospital
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Sep 1982
Decision
16d
Days
Class 2
Risk

K822761 is an FDA 510(k) clearance for the DELIVERY TUBE SET #2226. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Delta Medical Industries (Mchenry, US). The FDA issued a Cleared decision on September 30, 1982 after a review of 16 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 Delta Medical Industries devices

FDA 510(k) Submission Details - K822761

510(k) Number K822761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1982
Decision Date September 30, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 129d · This submission: 16d
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 534
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K822761.
BETATRON II
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COMPUTER INTERFACE MODULE CIM
K823035 · Y · Nov 1982
HARVARD APPARATUS SINGLE SPEED SYRINGE
K822989 · C.R. Bard, Inc. · Nov 1982
FLEXIFLO-II
K821661 · Abbott Laboratories · Jun 1982
MODEL AS6M INFUSION PUMP
K821069 · Baxter Healthcare Corp · Jun 1982
ETHOX FOOD PUMP STAND W/POLE CLAMP
K821148 · Ethox Corp. · May 1982