Cleared Traditional

K102833 - DISPOSABLE HEMODIALYSIS ACCESS CATHETER...

K102833 is an FDA 510(k) clearance for DISPOSABLE HEMODIALYSIS ACCESS CATHETER..., manufactured by Foshan Nanhai Bai HE Medical Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code MPB cleared through the Traditional 510(k) pathway after a 415-day FDA review.

K102833 · Foshan Nanhai Bai HE Medical Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
415d
Days
Class 2
Risk

K102833 is an FDA 510(k) clearance for the DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS. Classified as Catheter, Hemodialysis, Non-implanted (product code MPB), Class II - Special Controls.

Submitted by Foshan Nanhai Bai HE Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on November 18, 2011 after a review of 415 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Foshan Nanhai Bai HE Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K102833

510(k) Number K102833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date November 18, 2011
Days to Decision 415 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
285d slower than avg
Panel avg: 130d · This submission: 415d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MPB Device Classification - Class 2, Special Controls

Product Code MPB Catheter, Hemodialysis, Non-implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - MPB Catheter, Hemodialysis, Non-implanted

All 29
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