Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LJH — Predicate Candidate Screening
28 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
265 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162992 | Karl Storz UROMAT E.A.S.I. | Karl Storz Endoscopy America, Inc. | 2017-07-07 | 253 | 0 |
| K070873 | AMSURE BLADDER IRRIGATION SET | Amsino Intl., Inc. | 2007-12-19 | 265 | 0 |
| K071832 | MODIFCATION TO: SPYGLASS IRRIGATION SYSTEM | Medical Scientific, Inc. | 2007-09-18 | 77 | 0 |
| K063700 | SPYGLASS IRRIGATION SYSTEM | Medical Scientific, Inc. | 2007-02-08 | 57 | 0 |
| K062551 | NEXUS IRRIGATION TUBING SET | Nexus Medical, LLC | 2006-12-15 | 107 | 0 |
| K042457 | URO PRO | W.O.M. World of Medicine AG | 2004-10-25 | 45 | 1 |
| K040094 | PIGGYBACK IRRIGATING SYSTEM | Kosin Technologies, LLC | 2004-04-15 | 90 | 0 |
| K023808 | IRRIGATION SETS | International Medsurg Connection | 2003-03-10 | 116 | 0 |
| K010607 | MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4 | Benlan, Inc. | 2001-11-28 | 272 | 1 |
| K010122 | CONTINUOUS FLOW Y-TUBING | G.U.-Tek | 2001-06-04 | 139 | 0 |
| K001325 | FLO ASSISTANT, MODEL 4-250-00 | Northgate Technologies, Inc. | 2000-08-18 | 114 | 0 |
| K990909 | MTP UROPUMP DISPOSABLE TUBING SET | Mtp Medical Technical Promotion GmbH | 1999-06-09 | 83 | 0 |
| K981615 | KSEA UROPUMP | KARL STORZ Endoscopy-America, Inc. | 1998-07-08 | 63 | 0 |
| K980808 | ENDO FMS UROLOGY | Future Medical Systems, Inc. | 1998-05-08 | 66 | 0 |
| K971982 | KARL STORZ MODEL 203020 20 EQUIMAT | KARL STORZ Endoscopy-America, Inc. | 1997-08-12 | 75 | 0 |
| K970946 | MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET | Medline Industries, Inc. | 1997-06-10 | 88 | 0 |
| K962670 | NHMC IRRIGATION TRAY | National Healthcare Mfg. Corp. | 1996-08-14 | 36 | 0 |
| K960787 | TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS | Baxter Healthcare Corp | 1996-05-14 | 78 | 4 |
| K943361 | NORTHGATE FLOW ASSIST TUBING FOR UROLOGY | Northgate Technologies, Inc. | 1995-09-29 | 443 | 0 |
| K952583 | AQUISEN | Aquintel, Inc. | 1995-08-24 | 80 | 0 |
| K951569 | SURGACTIVATOR | Deschutes Medical Products, Inc. | 1995-06-06 | 63 | 0 |
| K945140 | URO-FLO | Mallinckrodt Group, Inc. | 1995-03-08 | 139 | 0 |
| K945210 | KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP | KARL STORZ Endoscopy-America, Inc. | 1995-02-07 | 105 | 0 |
| K940983 | THE KARL STORZ UROMAT(TM) | KARL STORZ Endoscopy-America, Inc. | 1994-09-20 | 203 | 0 |
| K941385 | PRO PULSE SYRINGE IRRIGATION SYSTEM | Giesy Consultants, Inc. | 1994-06-09 | 79 | 0 |
| K882295 | FILLING VOLUME OPTION | Eris Medical Technology | 1988-09-13 | 103 | 0 |
| K832040 | STERILE FLUID PRODUCING UNIT #EP550 | American Cystocope Makers, Inc. | 1983-09-29 | 97 | 0 |
| K822743 | SOLID STATE CONTINUOUS FLOW CONTROL | Widran Urological Group, Ltd. | 1982-09-24 | 14 | 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