Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
HHT — Predicate Candidate Screening
73 FDA 510(k) clearances under this product code; the 50 most recent screened below.
80 daysmedian FDA review time
385 days90th percentile
73clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182049 | exCellerator Cervical Collection Device | Excell Company, LLC | 2019-04-25 | 268 | 0 |
| K153128 | Kolplast Cervical Sample Collection Kit | Kolplast CI SA | 2017-01-13 | 442 | 0 |
| K141057 | DISPOSABLE CERVICAL BRUSH | Ningbo Hls Medical Products Co., Ltd. | 2015-05-14 | 385 | 0 |
| K111681 | HISTOBRUSH | Puritan Medical Products Company, LLC | 2012-01-19 | 218 | 0 |
| K083012 | PAPCONE | Otto Bock Pur Life Science GmbH | 2009-04-09 | 182 | 0 |
| K081522 | BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOL | Bio Nuclear Diagnostics, Inc. | 2008-12-05 | 189 | 0 |
| K072381 | SOFTPAP CERVICAL CELL COLLECTOR | Cytocore, Inc. | 2008-01-30 | 159 | 0 |
| K062433 | DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM | Diamics, Inc. | 2007-03-16 | 207 | 0 |
| K043369 | CERVEX-BRUSH COMBI | Rovers Medical Devices B.V. | 2005-02-02 | 56 | 0 |
| K042527 | SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 | Medical Action Industries, Inc. | 2004-11-08 | 52 | 0 |
| K041018 | DRG SOFTRELEASE | Doctor'S Research Group, Inc. | 2004-10-18 | 181 | 0 |
| K013258 | INPATH E2 COLLECTOR | Molecular Diagnostics | 2002-05-31 | 242 | 0 |
| K002520 | ROVERS SPATULA | Rovers Medical Devices B.V. | 2000-11-13 | 90 | 0 |
| K001119 | ROVERS ENDOCERVEX-BRUSH | Rovers Medical Devices B.V. | 2000-05-19 | 42 | 0 |
| K991595 | ORIBRUSH - WITH PROTECTIVE TIP - B001 | Orifice Medical AB | 1999-06-29 | 53 | 0 |
| K991593 | ORIBRUSH - STANDARD - B002 | Orifice Medical AB | 1999-06-29 | 53 | 0 |
| K983202 | HARWILL MEDICAL CERVITULA CERVICAL SPATULA | Harwill Medical (Pty) , Ltd. | 1999-03-15 | 182 | 0 |
| K983599 | SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT | Andwin Scientific | 1998-12-11 | 58 | 0 |
| K983428 | SAFETEX CERVICAL SCRAPER (PLASTIC) | Andwin Scientific | 1998-11-16 | 48 | 0 |
| K980356 | CERVICAL CYTOLOGY C-BRUSH MODEL CMB-1010 | Canadian Medical Brush, Inc. | 1998-04-16 | 77 | 0 |
| K971586 | DIGENE CERVICAL BRUSH | Digene Corp. | 1997-09-19 | 141 | 0 |
| K971849 | CYTOLOGY BRUSH | Team Technologies, Inc. | 1997-07-24 | 66 | 0 |
| K963801 | PAP BRUSH | Young OU Brush Co. | 1997-04-09 | 198 | 0 |
| K963685 | EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER | North Eos Industries, Inc. | 1996-10-11 | 38 | 0 |
| K961934 | PURITAN FOAM TIP SWAB MODEL 2197 | Hardwood Products Co., LP | 1996-07-09 | 53 | 0 |
| K960469 | DETECT CYTOLOGY BRUSH II | Cook Urological, Inc. | 1996-03-14 | 42 | 0 |
| K954562 | GYNETECH P.O.S. SPAP SMEAR CELL COLLECTION & TRANSPORT KIT | Gynetech, Inc. | 1995-12-22 | 81 | 0 |
| K950780 | AMSINO CERVICAL SCRAPER | Amsino Intl., Inc. | 1995-07-25 | 154 | 0 |
| K941472 | CERVEX-BRUSH PAP KIT | Rovers Diagnostic Devices | 1995-02-28 | 337 | 0 |
| K933870 | VIBA-BRUSH | Rovers B.V. | 1995-01-05 | 517 | 0 |
| K934732 | PELVIC EXAM TRAY | Medcare Custom Packaging, Inc. | 1994-12-30 | 457 | 0 |
| K942843 | CERVEX-BRUSH(R), STERILE, SPATULA, CERVICAL, CYTOLOGY | Rovers Diagnostic Devices | 1994-12-08 | 175 | 0 |
| K930955 | CERVEX-BRUSH | Rovers B.V. | 1994-05-24 | 455 | 0 |
| K912325 | MICRO-PAP(TM) KIT | Micro-Pap Corp. | 1994-05-02 | 1074 | 0 |
| K933628 | CYTOLOGY BRUSH | Bioteque America, Inc. | 1994-03-11 | 227 | 0 |
| K933415 | DETECT (TM) CYTOLOGY BRUSH | Cook Ob/Gyn | 1994-02-25 | 227 | 0 |
| K915844 | EXACT-TOUCH | Baal Assoc., Inc. | 1994-01-07 | 743 | 0 |
| K911432 | ACCELLON CERVICAL BIOSAMPLER | Medscand AB | 1993-09-03 | 885 | 0 |
| K923143 | CYTO PAK PAP SMEAR KIT | International Medical Equipment Brokers, Inc. | 1993-07-16 | 382 | 0 |
| K924908 | CELL COLLECTING BRUSH | Anderson Winn Paper Co. | 1993-04-13 | 195 | 0 |
| K911327 | CELL SWEEP | Reza S Mohajer, M.D. C/O Krass & Young | 1991-05-21 | 56 | 0 |
| K902995 | PC-BEADS POSTCOITAL TEST | Microscopy Research Innovations | 1991-01-31 | 206 | 0 |
| K902591 | CYTETTE(TM) CYTOLOGY BRUSH | Birchwood Laboratories, Inc. | 1990-09-10 | 90 | 0 |
| K902589 | CYTOSET(TM) | Birchwood Laboratories, Inc. | 1990-09-10 | 90 | 0 |
| K893229 | SPATULA FOR PAP SMEAR COLLECTION | Medical Device Inspection Co., Inc. | 1990-02-22 | 300 | 0 |
| K896065 | WALLACH CC/BRUSH | Wallach Surgical Devices, Inc. | 1990-01-04 | 78 | 0 |
| K895675 | PAP SMEAR TRAY | Intl. Cytobrush, Inc. | 1989-12-11 | 82 | 0 |
| K890848 | CERVEX-BRUSH | Unimar, Inc. | 1989-05-11 | 79 | 0 |
| K890706 | CYTOBRUSH | Laboratoire Ccd C/O Washington Regulatory Services | 1989-04-25 | 74 | 0 |
| K890013 | KOTEX SUPER MAXI PADS | Kimberly-Clark Corp. | 1989-04-25 | 112 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda