510(k) · Cleared
ClearedModification of the Ibi-1100 Steerable Electrophysiology Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irvine Biomedical, Inc. · DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Cleared on Jul 25, 1998 after a 30-day review. The FDA summary names no predicate by number. 1 of the 7 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Jul 25, 1998
- Review
- 30 days
- Class
- Class II
- Product code
- DRF
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 6 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- This deviceK982232 Modification of the Ibi-1100 Steerable Electrophysiology Catheter…Irvine Biomedical, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK171277 Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC · 2017
- Descendant · cites it directly · 1 of its ownK081329 Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2008
- Descendant · cites it directly · 0 of its ownK242225 Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic…Surgical Instrument Service and Savings, Inc. · 2024 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK203261 Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC · 2021
- Descendant · cites it directly · 0 of its ownK112232 Reprocessed Electrophysiology CathetersStryker Sustainability Solutions · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K242225 Medline ReNewal Reprocessed Abbott Inquiry…cites it directly · 2024
Most influential descendants
Showing 5 of 6 · See all- K171277Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC · 2017 · cites it directly1descendant
- K081329Reprocessed Electrophysiology CathetersAscent Healthcare Solutions · 2008 · cites it directly1descendant
- K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc. · 2024 · cites it directly0descendants
- K203261Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC · 2021 · cites it directly0descendants
- K112232Reprocessed Electrophysiology CathetersStryker Sustainability Solutions · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982232 | Modification of the Ibi-1100 Steerable Electrophysiology Catheter System | Irvine Biomedical, Inc. | 1998 | — |
| +1 | K171277 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2017 | — |
| +1 | K081329 | Reprocessed Electrophysiology Catheters | Ascent Healthcare Solutions | 2008 | — |
| +1 | K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter | Surgical Instrument Service and Savings, Inc. | 2024 | Class I |
| +1 | K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | Innovative Health, LLC | 2021 | — |
| +1 | K112232 | Reprocessed Electrophysiology Catheters | Stryker Sustainability Solutions | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 DRF device
- #1 K252794 Vision-MR™ Diagnostic Catheterscore 13.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (6)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171277 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | 2017 | 1 |
| K081329 | Reprocessed Electrophysiology Catheters | 2008 | 1 |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter Class I | 2024 | 0 |
| K203261 | Reprocessed Inquiry Steerable Diagnostic EP Catheter | 2021 | 0 |
| K112232 | Reprocessed Electrophysiology Catheters | 2011 | 0 |
| K101789 | Reprocessed Electrophysiology Diagnostic Catheters | 2010 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K242225Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterSurgical Instrument Service and Savings, Inc. · 2024 · Cites it directly · ◆ in the 2024 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K171277 (Innovative Health, LLC, 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DRF devicesDRF Catheter, Electrode Recording, Or Probe, Electrode Recording: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRF
45in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRF
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRF
508in 2025
MAUDE reports naming product code DRF, 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 | 2 | — | 2 | 120 |
| 2008 | 2 | — | 4 | 176 |
| 2009 | 7 | 243 | 0 | 122 |
| 2010 | 5 | 65 | 0 | 130 |
| 2011 | 3 | 190 | 6 | 245 |
| 2012 | 1 | — | 0 | 402 |
| 2013 | 2 | — | 0 | 310 |
| 2014 | 1 | — | 2 | 349 |
| 2015 | 3 | 29 | 1 | 327 |
| 2016 | 8 | 175 | 0 | 383 |
| 2017 | 7 | — | 0 | 458 |
| 2018 | 1 | — | 0 | 723 |
| 2019 | 10 | 163 | 0 | 669 |
| 2020 | 4 | — | 0 | 651 |
| 2021 | 12 | 124 | 0 | 625 |
| 2022 | 8 | 283 | 0 | 613 |
| 2023 | 5 | 45 | 0 | 685 |
| 2024 | 4 | — | 0 | 623 |
| 2025 | 3 | — | 0 | 508 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Electrogram recording and cardiac stimulation during diagnostic electrophysiologic studies. The catheters are commonly placed in the high right atrium, right ventricular apex, and the HIS bundle.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982232 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982232: Modification of the Ibi-1100 Steerable Electrophysiology Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982232
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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