510(k) · Cleared
ClearedAstronomer+with SLD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · DQK Computer, Diagnostic, Programmable
Cleared on Mar 1, 2001 after a 125-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Mar 1, 2001
- Review
- 125 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK003362 Astronomer+with SLDBoston Scientific Corp · 2001
- Descendant · cites it directly · 9 of its ownK110878 Rhythmview (TM)Topera, Inc. · 2011
- Descendant · 2 generations on · 8 of its ownK123295 Rhythm ViewTopera, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK142901 RhythmView WorkstationTopera, Inc. · 2014
- Descendant · 2 generations on · 5 of its ownK151245 Rhythm View Workstation (non-streaming, steaming option)Topera, Inc. · 2015
- Descendant · 2 generations on · 4 of its ownK161240 Rhythm View Workstation (non-streaming)Abbott Electrophysiology · 2016
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K110878Rhythmview (TM)Topera, Inc. · 2011 · cites it directly9descendants
- K123295Rhythm ViewTopera, Inc. · 2013 · 2 generations on8descendants
- K142901RhythmView WorkstationTopera, Inc. · 2014 · 2 generations on6descendants
- K151245Rhythm View Workstation (non-streaming, steaming option)Topera, Inc. · 2015 · 2 generations on5descendants
- K161240Rhythm View Workstation (non-streaming)Abbott Electrophysiology · 2016 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003362 | Astronomer+with SLD | Boston Scientific Corp | 2001 | — |
| +1 | K110878 | Rhythmview (TM) | Topera, Inc. | 2011 | — |
| +2 | K123295 | Rhythm View | Topera, Inc. | 2013 | — |
| +2 | K142901 | RhythmView Workstation | Topera, Inc. | 2014 | — |
| +2 | K151245 | Rhythm View Workstation (non-streaming, steaming option) | Topera, Inc. | 2015 | — |
| +2 | K161240 | Rhythm View Workstation (non-streaming) | Abbott Electrophysiology | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQK? 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 DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 112 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?
- Of its descendants, K110878 (Topera, Inc., 2011) has gone furthest, with 9 descendants of its own.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, 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 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
https://510kreport.com/device/K003362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003362: Astronomer+with SLD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003362
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026