Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Smiths Industries Medical Systems, Inc. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
270 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972385 | FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED | Smiths Industries Medical Systems, Inc. | 1998-01-20 | 208 | 0 |
| K965017 | REGIONAL ANESTHESIA TRAYS | Smiths Industries Medical Systems, Inc. | 1997-03-14 | 88 | 7 |
| K962175 | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE | Smiths Industries Medical Systems, Inc. | 1997-01-17 | 226 | 0 |
| K962931 | SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT | Smiths Industries Medical Systems, Inc. | 1996-10-21 | 84 | 0 |
| K963570 | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807 | Smiths Industries Medical Systems, Inc. | 1996-10-18 | 43 | 0 |
| K960429 | PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY T | Smiths Industries Medical Systems, Inc. | 1996-05-02 | 92 | 0 |
| K953485 | SIMS CPAP SYSTEM | Smiths Industries Medical Systems, Inc. | 1995-10-26 | 94 | 0 |
| K953483 | SIMS BLUE LINE ENDOBRONCHIAL TUBE | Smiths Industries Medical Systems, Inc. | 1995-10-24 | 91 | 0 |
| K932946 | WALLACE IV CANNULA | Smiths Industries Medical Systems, Inc. | 1995-09-01 | 806 | 0 |
| K932947 | WALLACE Y-CAN | Smiths Industries Medical Systems, Inc. | 1995-09-01 | 806 | 0 |
| K952516 | PRO-VENT, LINE DRAW, PULSATOR | Smiths Industries Medical Systems, Inc. | 1995-07-14 | 44 | 29 |
| K945777 | PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD | Smiths Industries Medical Systems, Inc. | 1994-12-22 | 27 | 0 |
| K935927 | CONCORD/PORTEX EPIDURAL CATHETERS | Smiths Industries Medical Systems, Inc. | 1994-09-09 | 270 | 0 |
| K942937 | SHARPSAFE CAT NO. 4105, 4115 AND 4120 | Smiths Industries Medical Systems, Inc. | 1994-08-25 | 64 | 0 |
| K936133 | PERCUTANEOUS TRACHEOSTOMY KIT | Smiths Industries Medical Systems, Inc. | 1994-03-23 | 90 | 0 |
| K935777 | SHARPSAFE, CAT. NO. 4125 | Smiths Industries Medical Systems, Inc. | 1994-02-28 | 87 | 0 |
| K935776 | SHARPSAFE, CAT. NO. 4126 | Smiths Industries Medical Systems, Inc. | 1994-02-28 | 87 | 0 |
| K935603 | EXTRACORPOREAL TEMPERATURE SENSOR | Smiths Industries Medical Systems, Inc. | 1994-02-15 | 89 | 0 |
| K935628 | SHARPSAFE CAT. NO. 4127 | Smiths Industries Medical Systems, Inc. | 1994-02-04 | 73 | 0 |
| K936134 | BERMAN AIRWAY | Smiths Industries Medical Systems, Inc. | 1994-01-28 | 36 | 0 |
| K934465 | DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE | Smiths Industries Medical Systems, Inc. | 1994-01-14 | 123 | 2 |
| K931735 | BLUE LINE(R) PDT(TM) PORTEX DIRECTIONAL TUBE | Smiths Industries Medical Systems, Inc. | 1993-05-18 | 41 | 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