Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sandhill Scientific, Inc. · Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
318 daysmedian FDA review time
624 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111013 | ACEM | Sandhill Scientific, Inc. | 2011-12-19 | 252 | 0 |
| K012232 | INSIGHT, MODEL S980000 | Sandhill Scientific, Inc. | 2002-06-07 | 326 | 2 |
| K013951 | SANDHILL SCIENTIFIC PEDIATEC PH PROBE | Sandhill Scientific, Inc. | 2002-02-28 | 90 | 0 |
| K002427 | SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-00 | Sandhill Scientific, Inc. | 2001-06-22 | 318 | 0 |
| K990441 | INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 | Sandhill Scientific, Inc. | 1999-05-12 | 90 | 0 |
| K984444 | INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 | Sandhill Scientific, Inc. | 1999-01-11 | 28 | 0 |
| K961056 | BIOVIEW MODEL S960000 | Sandhill Scientific, Inc. | 1996-06-06 | 80 | 0 |
| K942247 | SMALL BOWEL ANALYSIS SOFTWARE | Sandhill Scientific, Inc. | 1996-04-09 | 701 | 0 |
| K941801 | ANALGRAPH | Sandhill Scientific, Inc. | 1995-09-08 | 514 | 0 |
| K931963 | SANDHILL DISPOSABLE INTERNAL REFERENCE PH PROBE | Sandhill Scientific, Inc. | 1994-09-28 | 525 | 2 |
| K926218 | EISMAN-TRIES MEP (MULTIPLE ELECTRODE PROBE) | Sandhill Scientific, Inc. | 1994-08-26 | 624 | 0 |
| K931175 | SCHUSTER DISPOSABLE BALLOON PROBE | Sandhill Scientific, Inc. | 1994-04-01 | 388 | 2 |
| K932306 | MICROINFUSOR | Sandhill Scientific, Inc. | 1994-04-01 | 325 | 0 |
| K912772 | SUPERLOGGER | Sandhill Scientific, Inc. | 1992-02-07 | 228 | 0 |
| K904231 | MODEL OSP, SANDHILL AMS | Sandhill Scientific, Inc. | 1991-01-02 | 127 | 0 |
| K834512 | SANDMILL RMS | Sandhill Scientific, Inc. | 1984-02-21 | 62 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda