510(k) · Cleared
Recalled · Class II · 2016Medrad Intego Pet Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medrad, Inc. · FRN Pump, Infusion
Cleared on Jun 17, 2008 as substantially equivalent to K032771 (Medrad, Inc., 2003) and 2 other predicates after a 134-day review. Its family tree reaches back 2 generations to 2002. It has been recalled once.
- Decided
- Jun 17, 2008
- Review
- 134 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K021988 (2002). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021988 | Medrad Continuum MR Compatible Infusion System | Medrad, Inc. | 2002 | 1 |
| −1 | K032771 | Medrad Continuum MR Infusion System | Medrad, Inc. | 2003 | 1 |
| 0 (this device) | K080297 | Medrad Intego Pet Infusion System | Medrad, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 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 FRN? 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K032771 | Medrad Continuum MR Infusion SystemSummary page 1…MEDRAD Intego T M PET Infusion System PREDICATE DEVICES: · MEDRAD Continuum MR Infusion System (K032771) * Cal/Rad Mark VI/VDC-05 Dose Calibrator, Model 34-1… | 2003 |
| * | K030066 | Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165Summary page 1…(K032771) * Cal/Rad Mark VI/VDC-05 Dose Calibrator, Model 34-165 (K030066) * Personnel Protective Shield (Class I exempt) * Radio… | 2003 |
| * | K050456 | Medrad Avanta Fluid Management Injection SystemSummary page 1…em (Class II) * MEDRAD Avanta Fluid Management Injection System [Patient Administration Set] (K050456) INTENDED USE: The MEDRAD Intego PET Infusion System is intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) radio… | 2005 |
| * | — | Personnel Protective Shield Named without a submission number | |
| * | — | Radionuclide Rebreather System Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2016 | Class II | Z-0400-2017 | Process control | The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 1 company; a new generation was cleared every 4.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 3 other devices also cite its predicate K032771.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The MEDRAD Intego PET Infusion System is intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. The MEDRAD Intego PET Infusion System is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 (18F) radiation exposure during nuclear medicine diagnostic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080297 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080297: Medrad Intego Pet Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080297
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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