510(k) · Cleared
ClearedApplied Biosystems 7500 Fast DX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Biosystems, Inc. · NSU Instrumentation For Clinical Multiplex Test Systems
Cleared on Sep 30, 2008 after a 26-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Sep 30, 2008
- Review
- 26 days
- Class
- Class II
- Product code
- NSU
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK082562 Applied Biosystems 7500 Fast DXApplied Biosystems, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK141220 Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS…Thermo Fisher Scientific (Life Technologies Holdin · 2014
- Descendant · 2 generations on · 2 of its ownK181661 QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc. · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK093383 Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6…bioMerieux, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 0 of its ownK252243 Fastplex™ BCR-ABL (p210) %IS digital PCR KitSuzhou Precigenome, Ltd. Co; · 2026
- Descendant · 3 generations on · 0 of its ownK221869 BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141220Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS SoftwareThermo Fisher Scientific (Life Technologies Holdin · 2014 · cites it directly3descendants
- K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc. · 2019 · 2 generations on2descendants
- K093383Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens Easyq…bioMerieux, Inc. · 2010 · cites it directly1descendant
- K252243Fastplex™ BCR-ABL (p210) %IS digital PCR KitSuzhou Precigenome, Ltd. Co; · 2026 · 3 generations on0descendants
- K221869BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082562 | Applied Biosystems 7500 Fast DX | Applied Biosystems, Inc. | 2008 | — |
| +1 | K141220 | Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS Software | Thermo Fisher Scientific (Life Technologies Holdin | 2014 | — |
| +2 | K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Bio-Rad Laboratories, Inc. | 2019 | 1 |
| +1 | K093383 | Nuclisens Easyq Enterovirus V1.1., Nuclisens Easyq Director 2.6, Nuclisens… | bioMerieux, Inc. | 2010 | 1 |
| +3 | K252243 | Fastplex™ BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; | 2026 | — |
| +3 | K221869 | BCR-ABL1 (p210) % IS Kit (Digital PCR Method) | Suzhou Sniper Medical Technologies Co., Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 NSU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Affymetrix GeneChip Microarray instrument System Named without a submission number |
What descends from it? (6)
2 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, K141220 (Thermo Fisher Scientific (Life Technologies Holdin, 2014) has gone furthest, with 3 descendants of its own.
How does its category compare?
All NSU devicesNSU Instrumentation For Clinical Multiplex Test Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NSU
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · NSU
77in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NSU
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NSU
18in 2025
MAUDE reports naming product code NSU, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 85 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 3 | 77 | 0 | 30 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 4 | 3 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 1 | 24 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 2 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument with the SDS Software version 1.4 is a real-time nucleic acid amplification and detection system that measures nucleic acid signals from reverse transcribed RNA and converts them to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes. The 7500 Fast Dx is to be used only by technologists trained in laboratory techniques, procedures and on use of the analyzer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082562 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082562: Applied Biosystems 7500 Fast DX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082562
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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