510(k) · Cleared
ClearedBlood Pressure Monitor (Sphygmomanometer), Model HT-110
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nihon Seimitsu Sokki Co., Ltd. · DXQ Blood Pressure Cuff
Cleared on Jul 20, 2001 as substantially equivalent to K974080 (Johnson & Johnson Medical, Inc., 1998) and 1 other predicate after a 7-day review. Its family tree reaches back 2 generations to 1979. 14 later devices descend from it.
- Decided
- Jul 20, 2001
- Review
- 7 days
- Class
- Class II
- Product code
- DXQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K790810 (1979). 6 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK790810 Disposa-CufCrest Medical Equipment · 1979
- 1 generation backK974080 Critikon Soft Blood Pressure CuffJohnson & Johnson Medical, Inc. · 1998 · Recalled
- This deviceK012194 Blood Pressure Monitor (Sphygmomanometer), Model HT-110Nihon Seimitsu Sokki Co., Ltd. · 2001
- Descendant · cites it directly · 13 of its ownK043286 Aneroid Sphygmomanometer, Model BK2002Wenzhou Bokang Instrument Co.,Ltd · 2005
- Descendant · 2 generations on · 10 of its ownK173246 Aneroid SphygmomanometerWenzhou Bokang Instruments Co., Ltd. · 2018
- Descendant · 3 generations on · 9 of its ownK190902 RH non-Automated Blood Pressure Meter RH non-Automated Blood…Wenzhou Renhua Instruments Co., Ltd. · 2019
- Descendant · 4 generations on · 3 of its ownK192500 Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerHonsun (Nantong) Co., Ltd. · 2020
- Descendant · 5 generations on · 2 of its ownK211084 Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscopeShanghai Caremate Medical Device Co., Ltd. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K043286Aneroid Sphygmomanometer, Model BK2002Wenzhou Bokang Instrument Co.,Ltd · 2005 · cites it directly13descendants
- K173246Aneroid SphygmomanometerWenzhou Bokang Instruments Co., Ltd. · 2018 · 2 generations on10descendants
- K190902RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with…Wenzhou Renhua Instruments Co., Ltd. · 2019 · 3 generations on9descendants
- K192500Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerHonsun (Nantong) Co., Ltd. · 2020 · 4 generations on3descendants
- K211084Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscopeShanghai Caremate Medical Device Co., Ltd. · 2021 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K790810 | Disposa-Cuf | Crest Medical Equipment | 1979 | — |
| −1 | K974080 | Critikon Soft Blood Pressure Cuff | Johnson & Johnson Medical, Inc. | 1998 | 1 |
| 0 (this device) | K012194 | Blood Pressure Monitor (Sphygmomanometer), Model HT-110 | Nihon Seimitsu Sokki Co., Ltd. | 2001 | — |
| +1 | K043286 | Aneroid Sphygmomanometer, Model BK2002 | Wenzhou Bokang Instrument Co.,Ltd | 2005 | — |
| +2 | K173246 | Aneroid Sphygmomanometer | Wenzhou Bokang Instruments Co., Ltd. | 2018 | — |
| +3 | K190902 | RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter… | Wenzhou Renhua Instruments Co., Ltd. | 2019 | — |
| +4 | K192500 | Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer | Honsun (Nantong) Co., Ltd. | 2020 | — |
| +5 | K211084 | Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope | Shanghai Caremate Medical Device Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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 DXQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DXQ device
- #1 K254287 Medline Reusable Blood Pressure Cuffscore 13.3 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K974080 | Critikon Soft Blood Pressure CuffSummary page 1…) Predicate Devices The Nissei Blood Pressure Monitor, Model HT-110 is substantially equivalent to following: Device Manufacturer 510(k) K# Critikon Johnson & Johnson K974080 SoftCheck Cuff Statcorp, Inc. K940214 Device Description The device comprises tubing attached to a soft inelastic sleeve with a… | 1998 |
| * | K940214 | Statcorp Inc. Disposable Blood Pressure CuffSummary page 1…Pressure Monitor, Model HT-110 is substantially equivalent to following: Device Manufacturer 510(k) K# Critikon Johnson & Johnson K974080 SoftCheck Cuff Statcorp, Inc. K940214 Device Description The device comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that i… | 1994 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043286 | Aneroid Sphygmomanometer, Model BK2002 | 2005 | 13 |
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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 19.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K043286 (Wenzhou Bokang Instrument Co.,Ltd, 2005) has gone furthest, with 13 descendants of its own.
- 8 other devices also cite its predicate K974080.
How does its category compare?
All DXQ devicesDXQ Blood Pressure Cuff: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DXQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXQ
174in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXQ
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXQ
20in 2025
MAUDE reports naming product code DXQ, 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 | 2 | — | 0 | 3 |
| 2008 | 7 | 118 | 0 | 4 |
| 2009 | 5 | 57 | 0 | 2 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 5 | 121 | 1 | 5 |
| 2012 | 4 | 102 | 0 | 7 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 4 | 105 | 0 | 9 |
| 2015 | 10 | 59 | 0 | 23 |
| 2016 | 4 | 217 | 0 | 50 |
| 2017 | 2 | — | 0 | 67 |
| 2018 | 5 | 225 | 0 | 44 |
| 2019 | 3 | 44 | 0 | 41 |
| 2020 | 3 | 207 | 0 | 5 |
| 2021 | 4 | 105 | 0 | 12 |
| 2022 | 4 | 105 | 0 | 3 |
| 2023 | 5 | 79 | 0 | 20 |
| 2024 | 2 | — | 0 | 15 |
| 2025 | 3 | 174 | 1 | 20 |
| 2026 | 4 | 102 | 0 | — |
What is it indicated for?
Device is intended to be used by medical professionals or in the home for the measurement of systolic and diastolic pressure on adults. The device is intended to be manually attached to a patient and manually inflated along with a manual method for detecting Korotkoff sounds
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/K012194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012194: Blood Pressure Monitor (Sphygmomanometer), Model HT-110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012194
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026