Smiths Medical Asd, Inc.: FDA filings under this applicant name
FDA lists 52 510(k) clearances under the applicant name “Smiths Medical Asd, Inc.” (first 2004, latest 2024), plus 1 PMA decision, across 25 product codes in 4 review panels. Median 510(k) review time under this name: 108 days. Since 2017 the median was 254 days, against 201 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under ICU Medical, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 89 |
| 2013 | 2 | 467 |
| 2014 | 1 | 78 |
| 2015 | 0 | — |
| 2016 | 1 | 150 |
| 2017 | 4 | 232 |
| 2018 | 7 | 261 |
| 2019 | 0 | — |
| 2020 | 1 | 385 |
| 2021 | 2 | 172 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 254 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Smiths Medical Asd, Inc. took a median 254 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 201 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 5 | 5 |
| JOH | Tube Tracheostomy And Tube Cuff | 5 | 5 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 4 | 4 |
| DWJ | System, Thermal Regulating | 4 | 4 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 3 | 3 |
| CAZ | Anesthesia Conduction Kit | 3 | 3 |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 3 | 3 |
| MEG | Syringe, Antistick | 3 | 3 |
| BSO | Catheter, Conduction, Anesthetic | 2 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | 2 | 2 |
Plus 15 more product codes.
Review panels
- Anesthesiology (24)
- General Hospital (21)
- Cardiovascular (6)
- Clinical Chemistry (2)
Most recent Smiths Medical Asd, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232943 | Hypodermic Needle-Pro® EDGE Safety Device with Low Dead Space Syringe | QNQ | 2024-05-31 | 254 |
| K210833 | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula | JOH | 2021-11-26 | 252 |
| K211634 | Hypodermic Needle-Pro EDGE Safety Device | FMI | 2021-08-26 | 91 |
| K192375 | Intellifuse Administration and Intellifuse Blood Administration Sets | FPA | 2020-09-18 | 385 |
| K181699 | Level 1 Convective Warmer | DWJ | 2018-07-26 | 29 |
| K172800 | Portex® Lancet Point Spinal Needles with NRFit connectors, Portex® Pencil Point Spinal Needles with NRFit connectors | MIA | 2018-06-14 | 269 |
| K172823 | Portex NRFit Epidural Needles | BSP | 2018-06-12 | 267 |
| K172410 | Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters | BSP | 2018-06-01 | 296 |
| K172592 | CADD Yellow High Volume Administration Set with NRFit connector | PWH | 2018-05-17 | 261 |
| K173912 | BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube | JOH | 2018-05-08 | 137 |
42 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P900052 | PMA | PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYSTEM | 1991-04-22 |
Recalls
474 product recalls in 148 recall events; 138 initiated in the last five years. Most recent: 2025-04-10.
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.
Device clinical trials
An industry sponsor named Smiths Medical Asd, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01997099: A Workflow and Satisfaction Study Evaluating the Implementation of a New "Smart" Ambulatory Infusion System (Completed, started 2013-11)
- NCT02119351: A Study Evaluating the Clinical Performance of the ViaValve™ Safety IV Catheter (Completed, started 2013-07)
- NCT01792778: RIGHT IV Pilot Study (Completed, started 2013-02)
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Smiths Medical Asd, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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 Industries Medical Systems, Inc. (22 510(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 Medical Asd, Inc.?
FDA lists 52 510(k) clearances under the applicant name “Smiths Medical Asd, Inc.” (first 2004, latest 2024), plus 1 PMA decision, across 25 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 Medical Asd, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smiths Medical Asd, Inc. is 108 days. Since 2017: 254 days, versus 201 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Smiths Medical Asd, Inc.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 5); JOH (Tube Tracheostomy And Tube Cuff, 5); BSP (Needle, Conduction, Anesthetic (W/Wo Introducer), 4).
Next steps
- See all 52 Smiths Medical Asd, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Smiths Medical Asd, 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.