510(k) · Cleared

Recalled · Class II · 2019

Ion PGM Dx System

K170299510(k) TraditionalCleared Jun 22, 2017142-day reviewClass II21 CFR 862.2265Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Life Technologies Corporation · PFF High Throughput Dna Sequence Analyzer

Cleared on Jun 22, 2017 after a 142-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). It has been recalled 4 times.

Decided: Jun 22, 2017
Review: 142 days
Class: Class II
Product code: PFF
Recalls: 4
Predicates: 1

The summary cites one number, which could not be confirmed as its predicate (see the table below).

FIG. 1 — Lineage of K170299Source: FDA 510(k) database · How lineage is built

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.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K123989	Illumina MiSeqDx Platform Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 5 …21 CFR 862.9 Product Code: PFF - High throughput DNA sequence analyzer Predicate Devices – 21 CFR 807.92(a)(3): Predicates: Illumina MiSeqDx Platform, k123989 (DEN130011) Device Description – 21 CFR 807.92(a)(4): The Ion PGM™ Dx System is used for detection of human variant sequences f…

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 26, 2019	Class II	Z-0186-2020	Software design	Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant
Sep 26, 2019	Class II	Z-0185-2020	Software design	Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant
Sep 26, 2019	Class II	Z-0188-2020	Software design	Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant
Sep 26, 2019	Class II	Z-0187-2020	Software design	Torrent SuiteTM Dx analysis software, a component of the Ion PGM Dx Instrument System, incorrectly displays a positive result when a different analytical or de novo variant is detected at the same locus as a specified clinical variant

No ancestor or descendant has a Class I recall.

How does its category compare?

All PFF devices

PFF High Throughput Dna Sequence Analyzer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · PFF

1in 2017

2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PFF

Too few PFF 510(k)s in any year since 2007 to give a median.

Recalls per year · PFF

6in 2024

2007high 6 (2024) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PFF

2in 2025

2007high 2 (2025) · low 0 (2007)2025

MAUDE reports naming product code PFF, 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	0	—	0	0
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	0
2011	0	—	0	0
2012	0	—	0	0
2013	0	—	0	0
2014	0	—	0	0
2015	0	—	0	1
2016	0	—	0	0
2017	1	—	0	0
2018	0	—	0	0
2019	0	—	4	0
2020	0	—	0	0
2021	0	—	0	1
2022	0	—	1	1
2023	0	—	0	1
2024	0	—	6	1
2025	0	—	0	2
2026	0	—	1	—

What is it indicated for?

Read the full statement (119 words)

The Ion PGM™ Dx Instrument System is composed of a sequencing instrument that measures the hydrogen ions that are generated during the incorporation of nucleotides in the DNA sequencing reaction, and the ancillary instrumentation necessary for sample processing. This instrument system is used in conjunction with the instrument-specific Ion PGM™ Dx Library Kit, Ion OneTouch™ Dx Template Kit, Ion PGM™ Dx Sequencing Kit, and Ion 318™ Dx Chip Kit, and data analysis software. The Ion PGM™ Dx Instrument System is intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM™ Dx Instrument System is not intended for whole genome or de novo sequencing.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K170299 · printed Nov 3, 2026

Cite this page

510(k) Report. “K170299: Ion PGM Dx System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K170299

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026