Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hutchinson Technology, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
484 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K103613 | INPECTRA STO2 SPOT CHECK | Hutchinson Technology, Inc. | 2011-03-02 | 83 | 0 |
| K100915 | INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 | Hutchinson Technology, Inc. | 2010-04-30 | 29 | 0 |
| K061619 | INSPECTRA STO2 TISSUE OXYGENATION MONITOR | Hutchinson Technology, Inc. | 2006-07-12 | 33 | 0 |
| K053618 | INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 | Hutchinson Technology, Inc. | 2006-02-08 | 42 | 0 |
| K042020 | SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) | Hutchinson Technology, Inc. | 2004-09-15 | 50 | 0 |
| K023938 | MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL | Hutchinson Technology, Inc. | 2002-12-13 | 17 | 0 |
| K012759 | INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 | Hutchinson Technology, Inc. | 2002-01-17 | 153 | 0 |
| K963903 | BIOSPECTROMETER-NB OXIMETER IIII | Hutchinson Technology, Inc. | 1998-01-27 | 484 | 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