Ivac Corporation: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Ivac Corporation” (first 1996, latest 1996), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 458 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 |
|---|---|---|---|
| LSX | Controller, Closed-Loop, Blood-Pressure | 1 | 0 |
| LZH | Pump, Infusion, Enteral | 1 | 1 |
Review panels
- General Hospital (2)
Most recent Ivac Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K946168 | IVAC ENTERAL ADMIN. SETS, IVAC INFUSION PUMPS | LZH | 1996-03-21 | 458 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P860035 | PMA | TITRATOR MODEL 10K | 1987-12-17 |
Recalls
openFDA lists no recalls under a recalling firm named Ivac Corporation.
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 Ivac Corporation (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via LZH)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via LZH)
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.
- Ivac Medical Systems (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ivac Corporation?
FDA lists 1 510(k) clearance under the applicant name “Ivac Corporation” (first 1996, latest 1996), plus 1 PMA decision, 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 Ivac Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ivac Corporation is 458 days.
Which FDA product codes appear under Ivac Corporation?
The most frequent FDA product codes under this applicant name are LSX (Controller, Closed-Loop, Blood-Pressure, 1); LZH (Pump, Infusion, Enteral, 1).
Next steps
- See all 1 Ivac Corporation clearances with predicates and recalls
- Run predicate analysis for product code LSX, Ivac Corporation'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.