510(k) · Cleared
ClearedPain Vision, Model PS-2100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osachi Co., Ltd. · LLN Device, Vibration Threshold Measurement
Cleared on Jan 8, 2009 as substantially equivalent to K853608 (Neurotron, Inc., 1986) after a 457-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Jan 8, 2009
- Review
- 457 days
- Class
- Class I
- Product code
- LLN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K853608 (1986). No later device cites it as a predicate yet.
- Root · 1 generation backK853608 NeurometerNeurotron, Inc. · 1986
- This deviceK072882 Pain Vision, Model PS-2100Osachi Co., Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853608 | Neurometer | Neurotron, Inc. | 1986 | — |
| 0 (this device) | K072882 | Pain Vision, Model PS-2100 | Osachi Co., Ltd. | 2009 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K853608 | NeurometerSummary page 3…ification Name " : device, vibration threshold measurement - Product Code :LLN - Class <10 3. Identification of Legally Marketed Devices Name *: NEUROMETER K Number - :K853608 4. Product Overwew The PS-2100 is a type of Sensory-Nerve Threshold Measurement System Device. The electrical stimulus is applie… | 1986 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K853608.
How does its category compare?
All LLN devicesLLN Device, Vibration Threshold Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · LLN
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LLN
Too few LLN 510(k)s in any year since 2007 to give a median.
Recalls per year · LLN
No recall names LLN since 2007.
Adverse event reports per year · LLN
No MAUDE report names LLN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
PS-2100 is a device for the quantitative detection of sensory neurological impairments. The population of subjects for whom this device may be used include any individual capable of communicating their perception of cutaneous sensation. PS-2100’s examination may be conducted as part of a routine neurological examination or as a screening procedure. This device may be used by healthcare professionals to evaluate or diagnose a patient for peripheral neuropathy.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K072882 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072882: Pain Vision, Model PS-2100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072882
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026