Stellartech Research Corp. FDA Record
Stellartech Research Corp. has 0 FDA recalls, 8 inspections, 11 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Stellartech Research Corp." is on file.
- Latest inspection
- Apr 23, 2025 · NAI
- Latest 510(k)
- Oct 13, 2006
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 11 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 8 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 23, 2025 | Milpitas, CA | Devices | No Action Indicated (NAI) | 3010653929 |
| Mar 29, 2023 | Milpitas, CA | Devices | No Action Indicated (NAI) | 3010653929 |
| Dec 12, 2018 | Milpitas, CA | Devices | No Action Indicated (NAI) | 3010653929 |
| Aug 20, 2015 | Milpitas, CA | Devices | No Action Indicated (NAI) | 3010653929 |
| Aug 14, 2014 | Milpitas, CA | Devices | No Action Indicated (NAI) | 3010653929 |
| Feb 19, 2013 | Milpitas, CA | Devices | Voluntary Action Indicated (VAI) | 3010653929 |
| Nov 9, 2010 | Milpitas, CA | Devices | Voluntary Action Indicated (VAI) | 3010653929 |
| Mar 27, 2009 | Milpitas, CA | Devices | No Action Indicated (NAI) | 3010653929 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3010653929 | Milpitas, CA | 8 | Apr 23, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K061544 | STELLARTECH 100 COAGULATION SYSTEM | Oct 13, 2006 |
| K050831 | STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A | Apr 12, 2005 |
| K042909 | STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A | Nov 12, 2004 |
| K041383 | STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230 | Jun 14, 2004 |
| K040240 | STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) | Apr 1, 2004 |
| K032721 | MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) | Oct 6, 2003 |
| K032452 | MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230 | Aug 21, 2003 |
| K032062 | STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230) | Jul 29, 2003 |
| K023765 | STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) | Nov 29, 2002 |
| K013139 | STELLARTECH COAGULATION SYSTEM | Dec 18, 2001 |
| K994173 | STELLARTECH RADIOFREQUENCY GENERATOR,MODEL 1025A-115, STELLARTECH RADIOFREQUENCY GENERATOR, MODEL… | Jan 20, 2000 |
Stellartech Research Corp. and the FDA: common questions
Has Stellartech Research Corp. received an FDA warning letter?
No FDA warning letter addressed to the name "Stellartech Research Corp." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Stellartech Research Corp. received an FDA Form 483?
FDA has not published a Form 483 for "Stellartech Research Corp." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Stellartech Research Corp.?
The most recent FDA inspection on file ended Apr 23, 2025 at Milpitas, CA and was classified NAI. FDA has 8 inspections of Stellartech Research Corp. on file.
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