Cleared Traditional

NON-STERILE PERITONEAL ACCESS CATHET- (K830257) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830257 · Evermed, Inc. · Microbiology device
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Feb 1983
Decision
30d
Days
Class 2
Risk

K830257 is an FDA 510(k) clearance for the NON-STERILE PERITONEAL ACCESS CATHET-. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Evermed, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 24, 1983 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 876.5630 - the FDA microbiology 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 Evermed, Inc. devices

Submission Details

510(k) Number K830257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1983
Decision Date February 24, 1983
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKX System, Peritoneal, Automatic Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 Microbiology devices follow this clearance model.

Regulatory Peers - FKX System, Peritoneal, Automatic Delivery

All 32
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K830257.
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE
K833595 · Travenol Laboratories, S.A. · Nov 1983
AUTOMATIC PERITONEAL DIALYSIS CYCLER
K833065 · Travenol Laboratories, S.A. · Nov 1983
ABBOTT PATIENT ASSIST DEVICE
K830766 · Abbott Laboratories · Mar 1983
STERILE, DISPOS. SPIKE PROTECTOR-5C4138
K823777 · Travenol Laboratories, S.A. · Jan 1983
INPERSOL PERITONEAL DIALSIS CYCLER SET
K823217 · Abbott Laboratories · Nov 1982
EXTENSION SET TYPE DP
K822658 · Abbott Laboratories · Oct 1982