Smiths Industries Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Smiths Industries Medical Systems, Inc.” (first 1993, latest 1998), plus 1 PMA decision, across 13 product codes in 4 review panels. Median 510(k) review time under this name: 88 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 4 | 4 |
| JOH | Tube Tracheostomy And Tube Cuff | 4 | 4 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 3 | 3 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 2 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 2 | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 1 | 1 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| CBI | Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Smiths Industries Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972385 | FENESTRATED FLEXIBLE D.I.C. TRACHEOSTOMY TUBE CUFFED | JOH | 1998-01-20 | 208 |
| K965017 | REGIONAL ANESTHESIA TRAYS | CAZ | 1997-03-14 | 88 |
| K962175 | PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBE | JOH | 1997-01-17 | 226 |
| K962931 | SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT | JKA | 1996-10-21 | 84 |
| K963570 | SIMS ADULT LUMBAR PUNCTURE KIT (4800-20,4801-20,4806-22,4807-22) | FMJ | 1996-10-18 | 43 |
| K960429 | PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA | JOH | 1996-05-02 | 92 |
| K953485 | SIMS CPAP SYSTEM | BYE | 1995-10-26 | 94 |
| K953483 | SIMS BLUE LINE ENDOBRONCHIAL TUBE | CBI | 1995-10-24 | 91 |
| K932947 | WALLACE Y-CAN | FOZ | 1995-09-01 | 806 |
| K932946 | WALLACE IV CANNULA | FOZ | 1995-09-01 | 806 |
12 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P890024 | PMA | TROPHOCAN TM | 1990-08-09 |
Recalls
openFDA lists no recalls under a recalling firm named Smiths Industries Medical Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Smiths Medical Asd, Inc. (52 510(k)s)
- Smiths Medical MD, Inc. (20 510(k)s)
- Smiths Medical Pm, Inc. (5 510(k)s)
- Smiths Medical International , Ltd. (4 510(k)s)
- Smiths Medical (3 510(k)s)
- Smiths Medical Ads, Inc. (2 510(k)s)
- Smiths Medical International Ltd., Luton (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Smiths Industries Medical Systems, Inc.?
FDA lists 22 510(k) clearances under the applicant name “Smiths Industries Medical Systems, Inc.” (first 1993, latest 1998), plus 1 PMA decision, across 13 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Smiths Industries Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smiths Industries Medical Systems, Inc. is 88 days.
Which FDA product codes appear under Smiths Industries Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 4); JOH (Tube Tracheostomy And Tube Cuff, 4); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 3).
Next steps
- See all 22 Smiths Industries Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Smiths Industries Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.