Alaris Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Alaris Medical Systems, Inc.” (first 1998, latest 2004), across 8 product codes in 4 review panels. Median 510(k) review time under this name: 62 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 BD (Becton, Dickinson and Company), based on public ownership records.
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 |
|---|---|---|---|
| FRN | Pump, Infusion | 7 | 7 |
| DQA | Oximeter | 2 | 2 |
| MEA | Pump, Infusion, Pca | 2 | 2 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
| OLW | Index-Generating Electroencephalograph Software | 1 | 1 |
Review panels
- General Hospital (11)
- Anesthesiology (3)
- Cardiovascular (1)
- Neurology (1)
Most recent Alaris Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K043299 | MEDLEY PCA MODULE, MODEL 8120 | MEA | 2004-12-10 | 10 |
| K041241 | MEDLEY SYSTEM WITH BAR CODE MODULE, MODEL 8600 | FRN | 2004-07-06 | 56 |
| K031741 | MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 | CCK | 2004-02-09 | 250 |
| K032233 | MEDLEY PCA MODULE, MODEL 8120 | MEA | 2003-09-09 | 50 |
| K032147 | SIGNATURE EDITION INFUSION PUMP, SIGNATURE EDITION ADMINISTRATION SETS, MODELS 70XX, 71XX, 72XX, 7XXXX SERIES | FRN | 2003-07-25 | 11 |
| K030459 | MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) | FRN | 2003-04-04 | 52 |
| K023264 | MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 | FRN | 2002-12-19 | 80 |
| K022677 | MEDLEY SPO2 MODULE, MODEL 8210 & SPO2 SENSORS & CABLE | DQA | 2002-09-11 | 30 |
| K022209 | ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS | FPA | 2002-08-06 | 29 |
| K013087 | SINGLE DOSE DISPENSING PIN, MODEL 2201 | LHI | 2001-11-13 | 57 |
6 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2004-11-10.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Alaris Medical Systems, 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)
Frequently asked questions
How many FDA 510(k) clearances are listed under Alaris Medical Systems, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Alaris Medical Systems, Inc.” (first 1998, latest 2004), across 8 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 Alaris Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alaris Medical Systems, Inc. is 62 days.
Which FDA product codes appear under Alaris Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 7); DQA (Oximeter, 2); MEA (Pump, Infusion, Pca, 2).
Next steps
- See all 16 Alaris Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Alaris 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.