Smiths Medical MD, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Smiths Medical MD, Inc.” (first 2004, latest 2012), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 94 days. 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 | 1 | 171 |
| 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 4 | 4 |
| FRN | Pump, Infusion | 4 | 4 |
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | 4 | 4 |
| MRZ | Accessories, Pump, Infusion | 3 | 3 |
| LZG | Pump, Infusion, Insulin | 2 | 2 |
| DYB | Introducer, Catheter | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| MEA | Pump, Infusion, Pca | 1 | 1 |
Review panels
- General Hospital (17)
- Clinical Chemistry (2)
- Cardiovascular (1)
Most recent Smiths Medical MD, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112407 | SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS | DYB | 2012-02-09 | 171 |
| K111386 | MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS) | FRN | 2011-08-29 | 103 |
| K101180 | GRIPPER MICRO BLUNT CANNULA, NON-CORING SAFETY NEEDLE (GRIPPER MICRO NEEDLE) MODEL: 21-3253-24, 21-3258-24, 21-3262-24, | FPA | 2010-08-03 | 98 |
| K091181 | LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS | MRZ | 2009-06-12 | 50 |
| K082783 | CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE | MRZ | 2008-12-17 | 85 |
| K081156 | CADD MEDICATION CASSETTE RESERVOIR | FPA | 2008-07-18 | 86 |
| K080743 | LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP | FRN | 2008-04-25 | 39 |
| K072144 | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR | MEA | 2008-03-07 | 218 |
| K072955 | CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276) | MRZ | 2008-02-13 | 117 |
| K072657 | POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS AND POWER GRIPPER PLUS | LJT | 2007-12-14 | 85 |
10 earlier clearances. See the full list in Caduvo.
Recalls
70 product recalls in 20 recall events; 0 initiated in the last five years. Most recent: 2008-12-18.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Smiths Medical MD, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MRZ)
- 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 Medical Asd, Inc. (52 510(k)s)
- Smiths Industries Medical Systems, Inc. (22 510(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 MD, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Smiths Medical MD, Inc.” (first 2004, latest 2012), across 8 product codes in 3 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 MD, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Smiths Medical MD, Inc. is 94 days.
Which FDA product codes appear under Smiths Medical MD, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 4); FRN (Pump, Infusion, 4); LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular, 4).
Next steps
- See all 20 Smiths Medical MD, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Smiths Medical MD, 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.