510(k) · Cleared
ClearedReprocessed NRG Transseptal Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovative Health, LLC · QLZ Septostomy Catheter, Reprocessed
Cleared on Apr 4, 2023 as substantially equivalent to K200060 (Innovative Health, LLC, 2020) and 1 other predicate after a 508-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Apr 4, 2023
- Review
- 508 days
- Class
- Class II
- Product code
- QLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K011727 (2002). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK011727 Transseptal Needle/TrocarThomas Medical Products, Inc. · 2002 · Recalled
- 2 generations backK073326 NRG Transseptal NeedleBaylis Medical Co., Inc. · 2008 · Recalled
- 1 generation backK200060 Reprocessed NRG Transseptal NeedleInnovative Health, LLC · 2020
- This deviceK213584 Reprocessed NRG Transseptal NeedleInnovative Health, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011727 | Transseptal Needle/Trocar | Thomas Medical Products, Inc. | 2002 | 1 |
| −2 | K073326 | NRG Transseptal Needle | Baylis Medical Co., Inc. | 2008 | 1 |
| −1 | K200060 | Reprocessed NRG Transseptal Needle | Innovative Health, LLC | 2020 | — |
| 0 (this device) | K213584 | Reprocessed NRG Transseptal Needle | Innovative Health, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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 QLZ? 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 QLZ device
- #1 K200060 Reprocessed NRG Transseptal Needlescore 3.1 · 2 generations · no Class I recall
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K200060 | Reprocessed NRG Transseptal NeedleSummary page 5…Class II Product Code: QLZ Predicate Device: 510(k) Number 510(k) Device Manufacturer K200060 Reprocessed NRG Innovative Health Transseptal Needle K073… | 2020 |
| * | K073326 | NRG Transseptal NeedleSummary page 5…Manufacturer K200060 Reprocessed NRG Innovative Health Transseptal Needle K073326 NRG Transseptal Needle Baylis Medical Company Inc. Device Description: The reprocessed NR… | 2008 |
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All QLZ devicesQLZ Septostomy Catheter, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QLZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QLZ
Too few QLZ 510(k)s in any year since 2007 to give a median.
Recalls per year · QLZ
No recall names QLZ since 2007.
Adverse event reports per year · QLZ
1in 2023
MAUDE reports naming product code QLZ, 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 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213584 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213584: Reprocessed NRG Transseptal Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213584
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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