Cleared Traditional

K894857 - PEDI-TUBE(R) STYLET

K894857 is an FDA 510(k) clearance for PEDI-TUBE STYLET, manufactured by Biosearch Medical Products, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K894857 · Biosearch Medical Products, Inc. · Gastroenterology & Urology device
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Oct 1989
Decision
64d
Days
Class 2
Risk

K894857 is an FDA 510(k) clearance for the PEDI-TUBE(R) STYLET. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on October 3, 1989 after a review of 64 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 Biosearch Medical Products, Inc. devices

FDA 510(k) Submission Details - K894857

510(k) Number K894857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1989
Decision Date October 03, 1989
Days to Decision 64 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
67d faster than avg
Panel avg: 131d · This submission: 64d
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 K894857.
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HOLLISTER FEEDING TUBE ATTACHMENT DEVICE
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PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT
K885220 · Ethox Corp. · Sep 1989
ENTERA-FLO SPIKE SET
K893209 · Delmed, Inc. · Jul 1989
KENDALL CURITY STOMACH TUBES
K892439 · The Kendal Co. · Jun 1989