Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KNA · Predicate Candidate Screening
58 FDA 510(k) clearances under this product code; the 50 most recent screened below.
81 daysmedian FDA review time
409 days90th percentile
58clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130087 | PANPAC WORD/BARTHOLIN CATHETER | Panpac Medical Corporation | 2014-01-10 | 361 | 0 |
| K102141 | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET | Cook Urological, Inc. | 2011-05-06 | 281 | 0 |
| K093904 | GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER | Glenveigh Surgical, LLC | 2010-04-14 | 113 | 0 |
| K082939 | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 | Cook Urological, Inc. | 2009-09-03 | 336 | 0 |
| K062438 | BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 | Cook Ob/Gyn | 2006-10-27 | 67 | 0 |
| K060289 | EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 | Frontline Medical | 2006-07-07 | 151 | 0 |
| K013597 | TAMPONADE UTERINE BALLOON CATHETER SET | Cook Ob/Gyn | 2002-04-17 | 168 | 0 |
| K014248 | DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER | Urogyn , Ltd. | 2002-03-21 | 85 | 0 |
| K001590 | DND 101 | Urogyn , Ltd. | 2000-08-02 | 77 | 0 |
| K990738 | DR. JAHANGER'S CUTTER | M.S. Jahanger, MD | 1999-10-29 | 238 | 0 |
| K990045 | BERACLAMP, MODEL BC-1 | Poamax LLC | 1999-05-24 | 138 | 0 |
| K982464 | SCC-23 SAFETY CLAMP AND CUTTER | Women First Healthcare, Inc. | 1998-08-11 | 27 | 0 |
| K980717 | UROMED SLING KIT | Uromed Corp. | 1998-05-22 | 87 | 0 |
| K980237 | GYNEX ENDOSPECULUM | Gynex Corp. | 1998-04-08 | 75 | 0 |
| K972013 | NATIONAL MEDICAL HEALTHCARE CUSTOM OB/GYN KITS, TRAYS, OR PA | National Healthcare Mfg. Corp. | 1997-08-26 | 88 | 0 |
| K971277 | SAFE-T-CLAMP | Talon Medical, Ltd. | 1997-05-20 | 43 | 0 |
| K952527 | BALLOON UTERINE STENT | Cook Urological, Inc. | 1996-01-02 | 215 | 0 |
| K954619 | CORDGUARD II | Utah Medical Products, Inc. | 1995-12-21 | 77 | 0 |
| K951081 | OB/GYN PACKS | Sterile Concepts, Inc. | 1995-11-13 | 249 | 0 |
| K940907 | MADDEN SURGICAL THIMBLE | Kelley-Gilmer Medical Corp. | 1994-12-29 | 308 | 0 |
| K941641 | DISPOSABLE EMERGENCY OBSTETRICAL KIT | Gam Industries, Inc. | 1994-10-03 | 182 | 0 |
| K926532 | ENDO CERVICAL CURETTE | Thomasville Medical Assoc. | 1994-02-25 | 422 | 0 |
| K926537 | NEEDLE EXTENSIONS | Thomasville Medical Assoc. | 1994-02-24 | 421 | 0 |
| K926530 | MIYA HOOK | Thomasville Medical Assoc. | 1994-02-24 | 421 | 0 |
| K930110 | MICRO SURGERY NEEDLE HOLDERS | Thomasville Medical Assoc. | 1994-02-24 | 409 | 0 |
| K930031 | MICRO SURGERY SCISSORS | Thomasville Medical Assoc. | 1994-02-24 | 415 | 0 |
| K930727 | VARIOUS SCISSORS | Thomasville Medical Assoc. | 1994-02-24 | 378 | 0 |
| K926529 | Z CLAMP SCISSORS | Thomasville Medical Assoc. | 1994-02-24 | 421 | 0 |
| K930032 | RETRACTOR RODS | Thomasville Medical Assoc. | 1994-02-10 | 401 | 0 |
| K912075 | C-SECTION TRAY | Medical Device Inspection Co., Inc. | 1992-04-07 | 333 | 0 |
| K891398 | RETRACTOR RODS | Zinnanti Surgical Instruments, Inc. | 1989-05-11 | 58 | 0 |
| K891397 | GREENE-ARMYTAGE HEMOSTATIC FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-29 | 15 | 0 |
| K891399 | CORSON MYOMA GRASPING FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-29 | 15 | 0 |
| K891048 | OVUM FORCEPS-BARRET,JAVERTS,WILLET,HANSEN,COREY,MC | Zinnanti Surgical Instruments, Inc. | 1989-03-22 | 22 | 0 |
| K891045 | MIYA HOOK | Zinnanti Surgical Instruments, Inc. | 1989-03-22 | 22 | 0 |
| K891046 | SOPHER AND BIERER OVUM FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-22 | 22 | 0 |
| K891040 | MICRO SURGERY SCISSORS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | 17 | 0 |
| K891039 | MICRO SURGERY FORCEPS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | 17 | 0 |
| K891042 | MICRO SURGERY NEEDLE HOLDERS | Zinnanti Surgical Instruments, Inc. | 1989-03-17 | 17 | 0 |
| K884291 | COOK HYSTEROCATH(TM) | Cook, Inc. | 1988-12-08 | 57 | 0 |
| K880497 | WORD BARTHOLIN GLAND CATHETER CODE: 1005 | Hoosier Specialties, Inc. | 1988-03-24 | 48 | 0 |
| K863439 | INTRAUTERINE HEMOSTASIS BALLOON STENT | Mentor Corp. | 1987-06-02 | 270 | 0 |
| K871069 | MODIFIED HYSTEROSALPINGOGRAPY SET | Ackrad Laboratories | 1987-04-06 | 19 | 0 |
| K864623 | OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT | Xanmed Corp. | 1987-01-14 | 50 | 0 |
| K861385 | MILEX BARTHOLIN GLAND CATHETER | Milex Products, Inc. | 1986-06-16 | 63 | 0 |
| K844821 | MICROINFERTILITY NEEDLE HOLDER, TITANIUM | Precision Surgical Instrument, Inc. | 1985-01-16 | 37 | 0 |
| K844822 | MICROINFERTILITY SCISSORS, TITANIUM | Precision Surgical Instrument, Inc. | 1985-01-16 | 37 | 0 |
| K844823 | MICROINFERTILITY FORCEPS, TITANIUM | Precision Surgical Instrument, Inc. | 1985-01-16 | 37 | 0 |
| K842231 | ACKRAD HYSTEROSALPINGOGRAPHY SET | Ackrad Laboratories | 1984-09-19 | 106 | 0 |
| K810484 | OVARY FORCEPS | American V. Mueller | 1981-03-11 | 16 | 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