Elcam Medical Acal: FDA clearances and approvals
Elcam Medical Acal has 16 FDA 510(k) clearances (first 2003, latest 2023), across 9 product codes in 2 review panels. Median 510(k) review time: 100 days. Since 2017 its median was 54 days, against 170 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 171 |
| 2013 | 1 | 234 |
| 2014 | 1 | 77 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 54 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 511 |
| 2023 | 1 | 27 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Elcam Medical Acal's cleared 510(k)s took a median 54 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 170 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMG | Stopcock, I.V. Set | 8 | 8 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 1 | 1 |
| DRS | Transducer, Blood-Pressure, Extravascular | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| KZH | Introducer, Syringe Needle | 1 | 1 |
Review panels
- General Hospital (11)
- Cardiovascular (5)
Most recent Elcam Medical Acal 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231900 | A-TAP (previously called Arthrotap) | FMF | 2023-07-25 | 27 |
| K211204 | SafePort(TM) Manifold (or Stopcock) | FMG | 2022-09-15 | 511 |
| K190489 | Elcam Stopcocks and Manifolds | FMG | 2019-04-23 | 54 |
| K141254 | ELCAM STOPCOCKS AND MANIFOLDS | FMG | 2014-07-30 | 77 |
| K123084 | DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD | FMG | 2013-05-23 | 234 |
| K120253 | ELCAM VITAL SIGNS WIRELESS SYSTEM (VSWS) | DRG | 2012-07-16 | 171 |
| K120624 | ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) | DRS | 2012-06-08 | 99 |
| K111467 | FLEXI-Q DV AND DVR AUTO-INJECTORS | KZH | 2012-02-09 | 259 |
| K111016 | SAFEPORT MANIFOLD (TM) (OR STOPCOCK) | FPA | 2011-06-09 | 58 |
| K100425 | HASKAL TORQUE DEVICE | DQX | 2010-06-17 | 121 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Elcam Medical Acal.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Elcam Medical Acal have?
Elcam Medical Acal has 16 FDA 510(k) clearances (first 2003, latest 2023), across 9 product codes in 2 review panels.
How long does FDA take to clear Elcam Medical Acal's 510(k)s?
The median time from FDA receipt to decision across Elcam Medical Acal's cleared 510(k)s is 100 days. Since 2017: 54 days, versus 170 days for all cleared 510(k)s in the same product codes.
What devices does Elcam Medical Acal make?
Its most frequent FDA product codes are FMG (Stopcock, I.V. Set, 8); DQO (Catheter, Intravascular, Diagnostic, 1); DQX (Wire, Guide, Catheter, 1).
Has Elcam Medical Acal had device recalls?
openFDA lists no recalls under a recalling firm name matching Elcam Medical Acal. Related entities may recall under other names.
Next steps
- See all 16 Elcam Medical Acal clearances with predicates and recalls
- Run predicate analysis for product code FMG, Elcam Medical Acal's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.