Sandhill Scientific, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Sandhill Scientific, Inc.” (first 1984, latest 2011), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 285 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 |
|---|---|---|---|
| FFX | System, Gastrointestinal Motility (Electrical) | 6 | 6 |
| FFT | Electrode, Ph, Stomach | 4 | 4 |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 2 | 2 |
| FAD | Stent, Ureteral | 1 | 1 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 | 1 |
| FFZ | Cord, Electric, For Endoscope | 1 | 1 |
| HIR | Perineometer | 1 | 1 |
Review panels
Most recent Sandhill Scientific, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111013 | ACEM | FFZ | 2011-12-19 | 252 |
| K012232 | INSIGHT, MODEL S980000 | FFX | 2002-06-07 | 326 |
| K013951 | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | FFT | 2002-02-28 | 90 |
| K002427 | SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-0026 | FFX | 2001-06-22 | 318 |
| K990441 | INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 | FFX | 1999-05-12 | 90 |
| K984444 | INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 | FFX | 1999-01-11 | 28 |
| K961056 | BIOVIEW MODEL S960000 | KLA | 1996-06-06 | 80 |
| K942247 | SMALL BOWEL ANALYSIS SOFTWARE | FFX | 1996-04-09 | 701 |
| K941801 | ANALGRAPH | KLA | 1995-09-08 | 514 |
| K931963 | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE | FFT | 1994-09-28 | 525 |
6 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 5 recall events; 0 initiated in the last five years. Most recent: 2009-02-23.
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.
- Sandhill (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sandhill Scientific, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Sandhill Scientific, Inc.” (first 1984, latest 2011), across 7 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 Sandhill Scientific, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sandhill Scientific, Inc. is 285 days.
Which FDA product codes appear under Sandhill Scientific, Inc.?
The most frequent FDA product codes under this applicant name are FFX (System, Gastrointestinal Motility (Electrical), 6); FFT (Electrode, Ph, Stomach, 4); KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube, 2).
Next steps
- See all 16 Sandhill Scientific, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FFX, Sandhill Scientific, 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.