Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
DTW — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
77 daysmedian FDA review time
190 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150530 | Level Sensor, Level Sensor Tape | Medtronic, Inc. | 2015-05-08 | 67 | 0 |
| K041558 | STOCKERTIR PURGE CONTROL (APC) SYSTEM | Stockert Instrumente GmbH | 2004-07-02 | 22 | 0 |
| K992857 | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL | Rocky Mountain Research, Inc. | 1999-11-10 | 77 | 0 |
| K955152 | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEM | Stoeckert Instrumente | 1996-02-22 | 101 | 0 |
| K910599 | CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR | Jtl Medical Corp. | 1993-05-20 | 827 | 0 |
| K924354 | STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR | Sorin Biomedica, Fiat, USA, Inc. | 1993-02-18 | 190 | 0 |
| K915337 | CAPIOX LEVEL ALARM | Terumo Medical Corp. | 1992-02-21 | 87 | 0 |
| K900910 | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) | Cobe Laboratories, Inc. | 1990-05-22 | 84 | 0 |
| K900815 | SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL | 3M Company | 1990-05-09 | 77 | 8 |
| K873206 | MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE | Respiratory Support Products, Inc. | 1987-09-30 | 47 | 0 |
| K860076 | GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 | Gambro, Inc. | 1986-05-30 | 142 | 0 |
| K852407 | SENSOR TAPE CAT. NO. ST-45 | American Omni Medical, Inc. | 1985-10-21 | 137 | 0 |
| K843802 | STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR | Shiley, Inc. | 1984-12-27 | 91 | 0 |
| K831879 | UNIVERSAL LEVEL SENSOR | 3M Health Care, Sarns | 1983-07-26 | 43 | 0 |
| K823712 | BEL BLOOD LEVEL DETECTOR | R. Scott Bell | 1983-02-07 | 59 | 0 |
| K822821 | GAMBRO BLOOD LEVEL DETECTOR LCS 10 | Gambro, Inc. | 1982-10-18 | 28 | 0 |
| K781145 | MONITOR KITS, BLOOD LEVEL | 3M Health Care, Sarns | 1978-07-27 | 17 | 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