510(k) · Cleared
Cleared511 Kev Collimator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trionix Research Laboratory, Inc. · KPS System, Tomography, Computed, Emission
Cleared on May 29, 1997 as substantially equivalent to K873775 (Trionix Research Laboratory, Inc., 1988) and 2 other predicates after a 205-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- May 29, 1997
- Review
- 205 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K873775 (1988). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK873775 Triad Nuclear Imaging SystemTrionix Research Laboratory, Inc. · 1988
- This deviceK964438 511 Kev CollimatorTrionix Research Laboratory, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873775 | Triad Nuclear Imaging System | Trionix Research Laboratory, Inc. | 1988 | — |
| 0 (this device) | K964438 | 511 Kev Collimator | Trionix Research Laboratory, Inc. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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? (3)
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 |
|---|---|---|---|
| * | K873775 | Triad Nuclear Imaging SystemSummary page 2…/96 09:21 T301 480 4224 Response to @002 Question 1 o LH"I’AC)\ me st A . Page_Lof_z_ 510(k) Number (if known): __K964438 Devicc Name: 511 keV collimator for T88 ( K873775/R) - = Nuclear Medicine Device Indication For Use: To detect or image the distribution of radionuclides in the body or organ, u… | 1988 |
| * | K920776 | Cardiac Triad Nuclear Imaging SystemSummary page 3…09:21 T301 480 4224 H—fl en- Fres @002 Fte:;ponse to Quesion 1 . Page 2_of 2 510(k) Number (if known): __K964438 511 keV Collimator. for cardiac Triad (9" and 20") (K920776) (K9233457 Nuclear Medicine Device Devicc Name:_ Indication For Use: To detect or image the distribution of radionuclides in t… | 1992 |
| * | K923345 | Biad New Detector OptionSummary page 3…01 480 4224 H—fl en- Fres @002 Fte:;ponse to Quesion 1 . Page 2_of 2 510(k) Number (if known): __K964438 511 keV Collimator. for cardiac Triad (9" and 20") (K920776) (K9233457 Nuclear Medicine Device Devicc Name:_ Indication For Use: To detect or image the distribution of radionuclides in the body or… | 1992 |
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?
- None of the 3 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?
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).
Could be used with 511 keV photon imaging and photons of smaller energy simutaneously (e,q. 140 keV and 511 keV)
To detect or image the distribution of radionuclides in the body or organ, using the following techniquc(s).
Could be used with 511 keV photon imaging and photons ol smaller enerqgy simutaneously (e.g 140 keV an 511 keV)
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964438 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964438: 511 Kev Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964438
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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