510(k) · Cleared
ClearedBP-Spect V1.O
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syntermed, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Oct 4, 2004 as substantially equivalent to K020300 (Syntermed, Inc., 2002) after a 45-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Oct 4, 2004
- Review
- 45 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954874 (1996). No later device cites it as a predicate yet.
- Root · 4 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 3 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 2 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 1 generation backK020300 Northwestern Gated Blood Pool Spect (Numugas)Syntermed, Inc. · 2002
- This deviceK042258 BP-Spect V1.OSyntermed, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −3 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −2 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −1 | K020300 | Northwestern Gated Blood Pool Spect (Numugas) | Syntermed, Inc. | 2002 | — |
| 0 (this device) | K042258 | BP-Spect V1.O | Syntermed, Inc. | 2004 | — |
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 KPS? 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 KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K020300 | Northwestern Gated Blood Pool Spect (Numugas)Summary page 1…entricular function parameters from gated Tc99m blood pool SPECT studies. 3. Medical Device Equivalence: Northwestern Gated Blood Pool SPECT (NUMUGAS TM) Ref. 510(k) #: K020300 4. Device Description: The BP-SPECTTM is used to display gated wall motion and for quantifying parameters of left and right vent… | 2002 |
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?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, 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 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
The BP-SPECTTM software program should be used for the display of wall motion and quantification of left and right ventricular function parameters from gated Tc99m blood pool SPECT studies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042258: BP-Spect V1.O.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042258
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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