Intera Oncology, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Intera Oncology, Inc.” (first 2021, latest 2022), plus 2 PMA decisions, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 140 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 |
|---|---|---|
| 2021 | 1 | 182 |
| 2022 | 1 | 98 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Intera Oncology, Inc. took a median 140 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 162 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LKK | Pump, Infusion, Implanted, Programmable | 2 | 0 |
| PTI | Non-Coring (Huber) Needle | 2 | 2 |
Review panels
- General Hospital (4)
Most recent Intera Oncology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213823 | Intera Refill Kit | PTI | 2022-03-16 | 98 |
| K211121 | Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit | PTI | 2021-10-14 | 182 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P890055 | PMA | MEDSTREAM PROGRAMMABLE INFUSION PUMP SYSTEM | 1996-03-11 |
| P800036 | PMA | INFUSAID IMPLANTABLE INFUSION PUMP MODEL-100,200,4 | 1982-03-03 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-07-10.
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 Intera Oncology, Inc. (a text match, not an official crosswalk):
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LKK)
- A4220 — Refill kit for implantable infusion pump (via LKK)
- E0783 — Infusion pump system, implantable, programmable (includes all components, e.g., pump, catheter, connectors, etc.) (via LKK)
- E0782 — Infusion pump, implantable, non-programmable (includes all components, e.g., pump, catheter, connectors, etc.) (via LKK)
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.
- Intera Corp. (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intera Oncology, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Intera Oncology, Inc.” (first 2021, latest 2022), plus 2 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Intera Oncology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intera Oncology, Inc. is 140 days.
Which FDA product codes appear under Intera Oncology, Inc.?
The most frequent FDA product codes under this applicant name are LKK (Pump, Infusion, Implanted, Programmable, 2); PTI (Non-Coring (Huber) Needle, 2).
Next steps
- See all 2 Intera Oncology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LKK, Intera Oncology, 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.