510(k) · Cleared
ClearedApplied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermo Fisher Scientific (Life Technologies Holdin · NSU Instrumentation For Clinical Multiplex Test Systems
Cleared on May 22, 2014 as substantially equivalent to K082562 (Applied Biosystems, Inc., 2008) after a 10-day review. Its family tree reaches back 1 generation to 2008. 3 later devices descend from it.
- Decided
- May 22, 2014
- Review
- 10 days
- Class
- Class II
- Product code
- NSU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082562 (2008). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK082562 Applied Biosystems 7500 Fast DXApplied Biosystems, Inc. · 2008
- This deviceK141220 Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS…Thermo Fisher Scientific (Life Technologies Holdin · 2014
- Descendant · cites it directly · 2 of its ownK181661 QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK252243 Fastplex™ BCR-ABL (p210) %IS digital PCR KitSuzhou Precigenome, Ltd. Co; · 2026
- Descendant · 2 generations on · 0 of its ownK221869 BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd. · 2023
Most influential descendants
Showing 3 of 3 · See all- K181661QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemBio-Rad Laboratories, Inc. · 2019 · cites it directly2descendants
- K252243Fastplex™ BCR-ABL (p210) %IS digital PCR KitSuzhou Precigenome, Ltd. Co; · 2026 · 2 generations on0descendants
- K221869BCR-ABL1 (p210) % IS Kit (Digital PCR Method)Suzhou Sniper Medical Technologies Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082562 | Applied Biosystems 7500 Fast DX | Applied Biosystems, Inc. | 2008 | — |
| 0 (this device) | K141220 | Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS Software | Thermo Fisher Scientific (Life Technologies Holdin | 2014 | — |
| +1 | K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | Bio-Rad Laboratories, Inc. | 2019 | 1 |
| +2 | K252243 | Fastplex™ BCR-ABL (p210) %IS digital PCR Kit | Suzhou Precigenome, Ltd. Co; | 2026 | — |
| +2 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K082562 | Applied Biosystems 7500 Fast DXSummary page 1…Dx Device Class: Class 11 Classification Name: Instrumentation for Clinical Multiplex Test Systems (21 CFR 862.2570) Product Code: NSU Predicate Device: K082562, Applied Biosystems® 7500 Fast Dx Real-Time POR Instrument with SDS Software version 1.4 Device Description: The Applied B… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System | 2019 | 2 |
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?
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. 2014, 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 is a real-time nucleic acid amplification and five color fluorescence detection system for use with FDA cleared or approved tests on human-derived specimens. The 7500 Fast Dx Real-Time PCR instrument and SDS Software are intended for use in combination with in vitro diagnostic tests labeled for use on this instrument. The 7500 Fast Dx instrument is intended for use by laboratory professionals trained in laboratory techniques, procedures, and on use of the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141220: Applied Biosystems 7500 Fast DX Real-Time PCR Instrument with SDS Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141220
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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