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 Jul 30, 2020 as substantially equivalent to K073326 (Baylis Medical Co., Inc., 2008) after a 199-day review. Its family tree reaches back 2 generations to 2002. 1 later device descends from it.
- Decided
- Jul 30, 2020
- Review
- 199 days
- Class
- Class II
- Product code
- QLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011727 (2002). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK011727 Transseptal Needle/TrocarThomas Medical Products, Inc. · 2002 · Recalled
- 1 generation backK073326 NRG Transseptal NeedleBaylis Medical Co., Inc. · 2008 · Recalled
- This deviceK200060 Reprocessed NRG Transseptal NeedleInnovative Health, LLC · 2020
- Descendant · cites it directly · 0 of its ownK213584 Reprocessed NRG Transseptal NeedleInnovative Health, LLC · 2023
Most influential descendants
Showing 1 of 1 · See all- K213584Reprocessed NRG Transseptal NeedleInnovative Health, LLC · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011727 | Transseptal Needle/Trocar | Thomas Medical Products, Inc. | 2002 | 1 |
| −1 | K073326 | NRG Transseptal Needle | Baylis Medical Co., Inc. | 2008 | 1 |
| 0 (this device) | K200060 | Reprocessed NRG Transseptal Needle | Innovative Health, LLC | 2020 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 K213584 Reprocessed NRG Transseptal Needlescore 5.7 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K073326 | NRG Transseptal NeedleSummary page 5…tion Number: Class II, 21 CFR §870.5175 Product Code: QLZ Predicate Device: 510(k) Number 510(k) Device Manufacturer K073326 NRG Transseptal Needle Baylis Medical Company Inc. Device Description: The reprocessed NRG Transseptal Nee… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213584 | Reprocessed NRG Transseptal Needle | 2023 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K213584 (Innovative Health, LLC, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K073326.
How does its category compare?
All QLZ devicesQLZ Septostomy Catheter, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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/K200060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200060: Reprocessed NRG Transseptal Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200060
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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