Ivy Biomedical Systems, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Ivy Biomedical Systems, Inc.” (first 1986, latest 2024), across 11 product codes in 4 review panels. Median 510(k) review time under this name: 136 days. Since 2017 the median was 212 days, against 160 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.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 331 |
| 2017 | 1 | 58 |
| 2018 | 1 | 272 |
| 2019 | 0 | — |
| 2020 | 1 | 177 |
| 2021 | 2 | 182 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 246 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ivy Biomedical Systems, Inc. took a median 212 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 160 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 10 | 10 |
| DPS | Electrocardiograph | 4 | 4 |
| DQA | Oximeter | 3 | 3 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 3 | 3 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| DSK | Computer, Blood-Pressure | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| GWM | Device, Monitoring, Intracranial Pressure | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (19)
- Anesthesiology (4)
- Radiology (3)
- Neurology (1)
Most recent Ivy Biomedical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240087 | RT Carbon ECG Leads | DSA | 2024-09-13 | 246 |
| K202138 | Cardiac Trigger Monitor | DRT | 2021-05-14 | 287 |
| K203653 | MRI PPG Patient Cable | LNH | 2021-03-02 | 77 |
| K192852 | MRI ECG Patient Cable | LNH | 2020-03-28 | 177 |
| K171778 | MR Wireless Gating System, Model WGS-100 | LNH | 2018-03-14 | 272 |
| K170828 | Cardiac Trigger Monitor | DRT | 2017-05-17 | 58 |
| K151781 | Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor | DRT | 2016-05-27 | 331 |
| K110987 | CARDIAC TRIGGER MONITOR | DRT | 2011-07-22 | 105 |
| K091787 | MODEL 6000 TWO PARAMETER BEDSIDE MONITOR | DQA | 2009-10-09 | 114 |
| K091985 | UNIVERSAL PHYSIOLOGICAL MEASUREMENT MODULE | DRT | 2009-07-24 | 22 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ivy Biomedical 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Ivy Biomedical Systems, Inc. (a text match, not an official crosswalk):
- C8903 — Magnetic resonance imaging with contrast, breast; unilateral (via LNH)
- C8906 — Magnetic resonance imaging with contrast, breast; bilateral (via LNH)
- C8905 — Magnetic resonance imaging without contrast followed by with contrast, breast; unilateral (via LNH)
- C8908 — Magnetic resonance imaging without contrast followed by with contrast, breast; bilateral (via LNH)
- C8900 — Magnetic resonance angiography with contrast, abdomen (via LNH)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ivy Biomedical Systems, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Ivy Biomedical Systems, Inc.” (first 1986, latest 2024), across 11 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 Ivy Biomedical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ivy Biomedical Systems, Inc. is 136 days. Since 2017: 212 days, versus 160 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ivy Biomedical Systems, Inc.?
The most frequent FDA product codes under this applicant name are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 10); DPS (Electrocardiograph, 4); DQA (Oximeter, 3).
Next steps
- See all 27 Ivy Biomedical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRT, Ivy Biomedical 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.