Intersect Medical Products, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Intersect Medical Products, Inc.” (first 1979, latest 1994), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 35 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 |
|---|---|---|---|
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 4 | 4 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
Review panels
- Anesthesiology (4)
- General Hospital (1)
Most recent Intersect Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945543 | GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE | CAH | 1994-11-29 | 15 |
| K792516 | RESPIRATOR DISCONNECT ALARM CR 201 | CAP | 1980-01-09 | 35 |
| K792515 | RESPIRATOR DISCONNECT ALARM | CAP | 1980-01-09 | 35 |
| K791561 | RESPIRATOR DISCONNECT ALARM VA-100 | CAP | 1979-09-19 | 35 |
| K791527 | RESPIRATOR DISCONNECT ALARM CR201 | CAP | 1979-09-19 | 40 |
Recalls
openFDA lists no recalls under a recalling firm named Intersect Medical Products, 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.
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.
- Intersect Systems, Inc. (21 510(k)s)
- Intersect Ent. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intersect Medical Products, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Intersect Medical Products, Inc.” (first 1979, latest 1994), across 2 product codes in 2 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 Intersect Medical Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intersect Medical Products, Inc. is 35 days.
Which FDA product codes appear under Intersect Medical Products, Inc.?
The most frequent FDA product codes under this applicant name are CAP (Monitor, Airway Pressure (Includes Gauge And/Or Alarm), 4); CAH (Filter, Bacterial, Breathing-Circuit, 1).
Next steps
- See all 5 Intersect Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAP, Intersect Medical Products, 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.