Footprint Medical: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Footprint Medical” (first 2009, latest 2013), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 107 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 | 1 | 29 |
| 2013 | 1 | 96 |
| 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 |
|---|---|---|---|
| FOS | Catheter, Umbilical Artery | 3 | 3 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 3 | 3 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 | 2 |
| DYB | Introducer, Catheter | 1 | 1 |
| EZD | Catheter, Straight | 1 | 1 |
Review panels
Most recent Footprint Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130507 | FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER | LJS | 2013-06-03 | 96 |
| K120304 | FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER | FOS | 2012-03-01 | 29 |
| K102548 | FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE | KNT | 2010-11-26 | 84 |
| K093026 | FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER | DYB | 2010-02-24 | 148 |
| K093252 | FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER | LJS | 2009-12-17 | 62 |
| K091214 | FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER | FOS | 2009-09-25 | 151 |
| K091213 | FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN | FOS | 2009-09-25 | 151 |
| K091488 | FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C | LJS | 2009-09-14 | 118 |
| K090576 | FOOTPRINT URINARY DRAINAGE CATHETER | EZD | 2009-08-12 | 162 |
| K090559 | FOOTPRINT MEDICAL SILICONE FEEDING TUBE | KNT | 2009-05-04 | 63 |
Recalls
openFDA lists no recalls under a recalling firm named Footprint Medical.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Footprint Medical?
FDA lists 10 510(k) clearances under the applicant name “Footprint Medical” (first 2009, latest 2013), across 5 product codes in 3 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 Footprint Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Footprint Medical is 107 days.
Which FDA product codes appear under Footprint Medical?
The most frequent FDA product codes under this applicant name are FOS (Catheter, Umbilical Artery, 3); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 3); KNT (Tubes, Gastrointestinal (And Accessories), 2).
Next steps
- See all 10 Footprint Medical clearances with predicates and recalls
- Run predicate analysis for product code FOS, Footprint Medical'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.