Hutchinson Technology, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Hutchinson Technology, Inc.” (first 1998, latest 2011), across 1 product code in 1 review panel. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | 8 | 8 |
Review panels
Most recent Hutchinson Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103613 | INPECTRA STO2 SPOT CHECK | MUD | 2011-03-02 | 83 |
| K100915 | INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 | MUD | 2010-04-30 | 29 |
| K061619 | INSPECTRA STO2 TISSUE OXYGENATION MONITOR | MUD | 2006-07-12 | 33 |
| K053618 | INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 | MUD | 2006-02-08 | 42 |
| K042020 | SPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA) | MUD | 2004-09-15 | 50 |
| K023938 | MODIFICATION TO INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 | MUD | 2002-12-13 | 17 |
| K012759 | INSPECTRA TISSUE SPECTROMETER SYSTEM (INSPECTRA), MODEL 325 | MUD | 2002-01-17 | 153 |
| K963903 | BIOSPECTROMETER-NB OXIMETER IIII | MUD | 1998-01-27 | 484 |
Recalls
openFDA lists no recalls under a recalling firm named Hutchinson Technology, 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.
- Hutchinson Sante S.N.C. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hutchinson Technology, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Hutchinson Technology, Inc.” (first 1998, latest 2011), across 1 product code 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 Hutchinson Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hutchinson Technology, Inc. is 46 days.
Which FDA product codes appear under Hutchinson Technology, Inc.?
The most frequent FDA product codes under this applicant name are MUD (Oximeter, Tissue Saturation, 8).
Next steps
- See all 8 Hutchinson Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MUD, Hutchinson Technology, 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.