Vickers America Medical Corp.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Vickers America Medical Corp.” (first 1978, latest 1984), across 17 product codes in 6 review panels. Median 510(k) review time under this name: 57 days. 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 | 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 |
|---|---|---|---|
| FMZ | Incubator, Neonatal | 4 | 4 |
| FRN | Pump, Infusion | 2 | 2 |
| JQP | Calculator/Data Processing Module, For Clinical Use | 2 | 2 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 1 | 1 |
| BYF | Mask, Oxygen, Low Concentration, Venturi | 1 | 1 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 1 |
| FKW | Tip, Vessel | 1 | 1 |
| FMT | Warmer, Infant Radiant | 1 | 1 |
Plus 7 more product codes.
Review panels
- General Hospital (11)
- Anesthesiology (5)
- Clinical Chemistry (2)
- Hematology (2)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
Most recent Vickers America Medical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K840823 | TREONIC C30 | LDR | 1984-03-23 | 28 |
| K831838 | LABORATORY DATA MGMT SYSTEM SDMS | JQP | 1984-01-24 | 231 |
| K830748 | RESUSCITAIRE | FMT | 1983-06-22 | 105 |
| K830936 | TREONIC IP5 | FRN | 1983-04-12 | 19 |
| K813239 | OXYGENAIRE NURING INCUBATOR | FMZ | 1982-01-28 | 72 |
| K813238 | NEOCARE BABY-CONTROLLED INCUBATOR | FMZ | 1982-01-22 | 66 |
| K811865 | VMA PEDIATRIC APNEA MATTRESS | BZQ | 1981-07-31 | 30 |
| K810792 | NEOCARE TEMPERATURE MONITOR | FMZ | 1981-04-29 | 37 |
| K810571 | NEOCARE OXYGEN MONITOR | CCL | 1981-03-11 | 8 |
| K810067 | 140 NEOCARE AIR CONTROLLED INCUBATOR | FMZ | 1981-03-11 | 57 |
12 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vickers America Medical Corp..
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 Vickers America Medical Corp. (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.
- Vickers , Ltd. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vickers America Medical Corp.?
FDA lists 22 510(k) clearances under the applicant name “Vickers America Medical Corp.” (first 1978, latest 1984), across 17 product codes in 6 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 Vickers America Medical Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vickers America Medical Corp. is 57 days.
Which FDA product codes appear under Vickers America Medical Corp.?
The most frequent FDA product codes under this applicant name are FMZ (Incubator, Neonatal, 4); FRN (Pump, Infusion, 2); JQP (Calculator/Data Processing Module, For Clinical Use, 2).
Next steps
- See all 22 Vickers America Medical Corp. clearances with predicates and recalls
- Run predicate analysis for product code FMZ, Vickers America Medical Corp.'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.