Cleared Traditional

K890283 - CYTEX ONE AND CYTEX TWO

K890283 is an FDA 510(k) clearance for CYTEX ONE AND CYTEX TWO, manufactured by Anderson Winn Paper Co.. The device is a Class 2 Obstetrics & Gynecology device with product code HHT cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K890283 · Anderson Winn Paper Co. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
56d
Days
Class 2
Risk

K890283 is an FDA 510(k) clearance for the CYTEX ONE AND CYTEX TWO. Classified as Spatula, Cervical, Cytological (product code HHT), Class II - Special Controls.

Submitted by Anderson Winn Paper Co. (Burbank, US). The FDA issued a Cleared decision on March 16, 1989 after a review of 56 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 Anderson Winn Paper Co. devices

FDA 510(k) Submission Details - K890283

510(k) Number K890283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1989
Decision Date March 16, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 160d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HHT Device Classification - Class 2, Special Controls

Product Code HHT Spatula, Cervical, Cytological
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 - HHT Spatula, Cervical, Cytological

All 35
Devices cleared under the same product code (HHT) and FDA review panel - the closest regulatory comparables to K890283.
WALLACH CC/BRUSH
K896065 · Wallach Surgical Devices, Inc. · Jan 1990
KOTEX SUPER MAXI PADS
K890013 · Kimberly-Clark Corp. · Apr 1989
ENDO CERVICAL CURETTE - EVANS, RANDALL, GUSBERG
K891032 · Zinnanti Surgical Instruments, Inc. · Mar 1989
ROCKET ENDOCERVICAL BRUSH
K885274 · A & A Medical, Inc. · Mar 1989
ROCKET CERVICAL SPATULA
K884042 · A & A Medical, Inc. · Oct 1988
C-E BRUSH
K881921 · Surgipath Medical Industries, Inc. · Jul 1988