Cleared Traditional

K830986 - RECTAL TUBES

K830986 is an FDA 510(k) clearance for RECTAL TUBES, manufactured by Medovations, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K830986 · Medovations, Inc. · Gastroenterology & Urology device
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May 1983
Decision
59d
Days
Class 2
Risk

K830986 is an FDA 510(k) clearance for the RECTAL TUBES. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Medovations, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1983 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology 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 Medovations, Inc. devices

FDA 510(k) Submission Details - K830986

510(k) Number K830986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1983
Decision Date May 27, 1983
Days to Decision 59 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 131d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 469
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K830986.
MILLER-ABBOTT TUBE
K830998 · Medovations, Inc. · Jun 1983
CANTOR TUBE
K831009 · Medovations, Inc. · Jun 1983
STOMACH TUBE
K830985 · Medovations, Inc. · May 1983
LEVIN TUBE
K830987 · Medovations, Inc. · May 1983
ARGYLE MADEN SILICONE GASTROSTOMY TUBE
K830794 · Sherwood Medical Co. · May 1983
ENTERAL PUMP SET
K831167 · Biosearch Medical Products, Inc. · May 1983