Cleared Traditional

K021055 - BUSSE UMBILICAL CORD CLAMP CUTTER

K021055 is an FDA 510(k) clearance for BUSSE UMBILICAL CORD CLAMP CUTTER, manufactured by Busse Hospital Disposables, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HFW cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K021055 · Busse Hospital Disposables, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
28d
Days
Class 2
Risk

K021055 is an FDA 510(k) clearance for the BUSSE UMBILICAL CORD CLAMP CUTTER. Classified as Clamp, Umbilical (product code HFW), Class II - Special Controls.

Submitted by Busse Hospital Disposables, Inc. (Huntington, US). The FDA issued a Cleared decision on April 29, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology 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 Busse Hospital Disposables, Inc. devices

FDA 510(k) Submission Details - K021055

510(k) Number K021055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2002
Decision Date April 29, 2002
Days to Decision 28 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d faster than avg
Panel avg: 160d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HFW Device Classification - Class 2, Special Controls

Product Code HFW Clamp, Umbilical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HFW Clamp, Umbilical

All 19
Devices cleared under the same product code (HFW) and FDA review panel - the closest regulatory comparables to K021055.
JOEY CLAMP OPENING TOOL
K041332 · Maternus, Inc. · Jun 2004
SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE
K020718 · Precision Dynamics Corp. · Jun 2002
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
K012917 · Dynarex Corp. · Nov 2001
POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385
K010835 · Busse Hospital Disposables, Inc. · Apr 2001
UMBICUT
K000227 · Pollak (Intl.), Ltd. · Apr 2000
UMBILICAL CORD CLAMP
K994367 · Medical Sales Co. · Mar 2000