510(k) · Cleared
ClearedMini-Logger Series 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mini-Mitter Co., Inc. · GWK Conditioner, Signal, Physiological
Cleared on Sep 21, 1999 as substantially equivalent to K914085 (Vitalog Monitoring,Inc., 1991) after a 176-day review. Its family tree reaches back 1 generation to 1991. 138 later devices descend from it.
- Decided
- Sep 21, 1999
- Review
- 176 days
- Class
- Class II
- Product code
- GWK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K914085 (1991). 138 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK914085 HMS-5000Vitalog Monitoring,Inc. · 1991
- This deviceK991045 Mini-Logger Series 2000Mini-Mitter Co., Inc. · 1999
- Descendant · cites it directly · 132 of its ownK052489 ActiheartRespironics, Inc. · 2005
- Descendant · 2 generations on · 99 of its ownK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
- Descendant · 2 generations on · 71 of its ownK113054 EquivitalHidalgo Limited · 2012
- Descendant · 3 generations on · 70 of its ownK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
- Descendant · 4 generations on · 43 of its ownK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015
Showing 5 of 138 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 138 · See all- K052489ActiheartRespironics, Inc. · 2005 · cites it directly132descendants
- K061993Equivital, Model EQ-01Hidalgo Limited · 2006 · 2 generations on99descendants
- K113054EquivitalHidalgo Limited · 2012 · 2 generations on71descendants
- K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc. · 2014 · 3 generations on70descendants
- K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015 · 4 generations on43descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K914085 | HMS-5000 | Vitalog Monitoring,Inc. | 1991 | — |
| 0 (this device) | K991045 | Mini-Logger Series 2000 | Mini-Mitter Co., Inc. | 1999 | — |
| +1 | K052489 | Actiheart | Respironics, Inc. | 2005 | — |
| +2 | K061993 | Equivital, Model EQ-01 | Hidalgo Limited | 2006 | — |
| +2 | K113054 | Equivital | Hidalgo Limited | 2012 | — |
| +3 | K141167 | Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software… | Vitalconnect, Inc. | 2014 | — |
| +4 | K152139 | Vital Connect Platform, HealthPatch MD, VitalPatch | Vitalconnect, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 10 | 0 |
| 2021 | 5 | 0 |
| 2022 | 10 | 0 |
| 2023 | 16 | 0 |
| 2024 | 13 | 0 |
| 2025 | 19 | 0 |
| 2026 | 8 | 0 |
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 GWK? 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 |
|---|---|---|---|
| * | K914085 | HMS-5000Summary page 1…ata Logging Device Classification Name: Physiological signal conditioner (Product Code GYE) 10.1.3 Identification of predicate device Vitalog HMS-5000 510(k) Number : K914085 Page 23 Mini Mitter Co, Inc. 510(k) Premarket Notification Mini-Logger® June 22, 1999 10.1.4 Device Description… | 1991 |
What descends from it? (138)
See all 1382 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All GWK devicesGWK Conditioner, Signal, Physiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWK
FDA has decided no GWK device since 2007.
Median 510(k) review, days · GWK
Too few GWK 510(k)s in any year since 2007 to give a median.
Recalls per year · GWK
No recall names GWK since 2007.
Adverse event reports per year · GWK
1in 2013
MAUDE reports naming product code GWK, not matched to any one device; reports are not rates.
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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 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?
The Mini-Logger® Series 2000 (hereafter referred to as Mini-Logger) is a compact, lightweight, physiological data logger for monitoring heart rate, inter-beat-interval (IBI), temperature, ambient light, and activity. The Mini-Logger® can be used in behavioral and circadian rhythm studies, sleep research, occupational health and sports medicine research, and obesity/weight loss studies. The device can be used for any assessment of human heart rate or IBI, temperature, and activity that requires logging of data over time and an integrated analysis of the aforementioned parameters. The Mini-Logger® may be used in any instance where quantifiable analysis of physiological data is desirable.
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/K991045 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991045: Mini-Logger Series 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991045
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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