Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sorensen Research — Predicate Candidate Screening
69 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
64 days90th percentile
69clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K833674 | ACCURATE MEASUREMENT DEVICE KG-AMD | Sorensen Research | 1984-01-25 | 99 | 0 |
| K833673 | ACCURATE MEASUREMENT DEVICE EZ-AMD | Sorensen Research | 1983-12-29 | 72 | 0 |
| K833095 | TRANSDUCER DOME SD105 | Sorensen Research | 1983-11-03 | 52 | 0 |
| K833096 | TRANSDUCER DOME DS106 | Sorensen Research | 1983-11-03 | 52 | 0 |
| K833094 | TRANSDUCER DOME SD104 | Sorensen Research | 1983-11-03 | 52 | 0 |
| K832957 | FLOW-DIRECTED HEPARIN COATED THERMODIL | Sorensen Research | 1983-09-29 | 29 | 1 |
| K831506 | DISP. TRANSDUCER W/MONITORING KIT TRANS | Sorensen Research | 1983-08-12 | 93 | 1 |
| K831939 | TALL FLOOR STAND TFS-01 | Sorensen Research | 1983-07-19 | 33 | 0 |
| K831505 | THORACIC GAUGE #TG-60 -VACUUM REGULATOR | Sorensen Research | 1983-07-12 | 62 | 0 |
| K820706 | WATERLESS SEAL & VACUUM REGULATOR | Sorensen Research | 1982-04-09 | 24 | 0 |
| K813464 | DISPOSABLE TRANSDUCER | Sorensen Research | 1982-01-07 | 27 | 1 |
| K812757 | SORENSON THERMODILUTION CARDIAC COMPUT | Sorensen Research | 1981-11-02 | 33 | 0 |
| K812800 | FLOW-DIRECTED THERMODILUTION CATHETER | Sorensen Research | 1981-10-20 | 14 | 1 |
| K812052 | MYOCATH CATOLOG NO. MCK-A | Sorensen Research | 1981-10-06 | 77 | 0 |
| K812324 | FLOW-DIRECTED THERMODILUTION CATHETER | Sorensen Research | 1981-09-25 | 39 | 0 |
| K812326 | SORENSON SUBCLAVIAN CATHETER SSC-8 | Sorensen Research | 1981-09-25 | 39 | 0 |
| K812325 | INTK-08 8 FRENCH INTRODUCER KIT W/SIDE | Sorensen Research | 1981-09-21 | 35 | 0 |
| K811228 | SORENSON CATALOG #IFL-120S | Sorensen Research | 1981-06-09 | 36 | 0 |
| K811203 | SAF SINGLE-USE AEROSOL FILTER | Sorensen Research | 1981-05-21 | 20 | 0 |
| K803011 | DISPOSABLE DIAPHRAGM DONE | Sorensen Research | 1980-12-31 | 33 | 0 |
| K802961 | TRANSDUCER DOME, CAT.#SD-101 | Sorensen Research | 1980-12-31 | 40 | 0 |
| K801478 | SSC8 SORENSON SUBCLAVIAN CATHETER | Sorensen Research | 1980-08-27 | 64 | 0 |
| K801048 | ACCUDYNAMIC | Sorensen Research | 1980-05-14 | 9 | 0 |
| K791636 | ACCUNAMIC | Sorensen Research | 1979-10-04 | 44 | 0 |
| K790841 | TG 2, TRI-GARD PRESSURE MONITOR | Sorensen Research | 1979-06-27 | 56 | 0 |
| K781552 | MEDIASTINAL DRAINAGE TUBE SET MDT-32TC2 | Sorensen Research | 1978-10-26 | 44 | 0 |
| K781553 | MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2 | Sorensen Research | 1978-10-26 | 44 | 0 |
| K781550 | TRAUMA DRAINAGE SET 72T-28TTC | Sorensen Research | 1978-10-26 | 44 | 0 |
| K781551 | TRAUMA DRAINAGE SET 72T-32TTC | Sorensen Research | 1978-10-26 | 44 | 0 |
| K780465 | VOLUME CONTROL DEVICE VCD-150 | Sorensen Research | 1978-06-02 | 72 | 0 |
| K780529 | MYOCATH KIT | Sorensen Research | 1978-05-09 | 36 | 0 |
| K780145 | BLOOD FILTER, MICROEMBOLI-ATS-F10 | Sorensen Research | 1978-02-02 | 3 | 0 |
| K772280 | RECEPTAL ATS MEDIASTINAL LINER | Sorensen Research | 1978-01-03 | 25 | 0 |
| K772196 | RECEPTAL ATS TRAUMA KGA1900L | Sorensen Research | 1977-12-22 | 24 | 0 |
| K772148 | CATHETER, FEMORAL VEIN, SF 6 | Sorensen Research | 1977-11-29 | 15 | 0 |
| K772146 | CATHETER, VEIN, FEMORAL, SF 10 | Sorensen Research | 1977-11-29 | 15 | 0 |
| K772147 | GW 35 GUIDE WIRE | Sorensen Research | 1977-11-28 | 14 | 0 |
| K771491 | A.V. FISTULA NEEDLE SET (#364) | Sorensen Research | 1977-08-16 | 11 | 0 |
| K771492 | A.V. FISTULA NEEDLE SET (#351) | Sorensen Research | 1977-08-16 | 11 | 0 |
| K771495 | A.V. FISTULA NEEDLE SET (#361) | Sorensen Research | 1977-08-16 | 11 | 0 |
| K771493 | A.V. FISTULA NEEDLE SET (#341) | Sorensen Research | 1977-08-16 | 11 | 0 |
| K771494 | A.V. FISTULA NEEDLE SET (354) | Sorensen Research | 1977-08-16 | 11 | 0 |
| K771490 | A.V. FISTULA NEEDLE SET (#344) | Sorensen Research | 1977-08-16 | 11 | 0 |
| K770717 | IONTOPHORESIS SYSTEM MODULE, DM 500 | Sorensen Research | 1977-08-15 | 119 | 0 |
| K771042 | INTRODUCER, CAT. #INT-05FR. | Sorensen Research | 1977-07-13 | 34 | 0 |
| K771041 | INTRODUCER, CAT. #INT-06FR. | Sorensen Research | 1977-07-13 | 34 | 0 |
| K771040 | INTRODUCER, CAT. #INT-07FR. | Sorensen Research | 1977-06-29 | 19 | 0 |
| K770043 | DNC 161 VINCA-FLO | Sorensen Research | 1977-01-14 | 4 | 0 |
| K770046 | DNC 142 VINCA-FLO | Sorensen Research | 1977-01-14 | 4 | 0 |
| K770044 | DNC 141 VINCA-FLO | Sorensen Research | 1977-01-14 | 4 | 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