510(k) · Cleared
ClearedIdrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien, LLC, Formerly Registered AS Tyco Healthca · GDW Staple, Implantable
Cleared on Oct 13, 2010 as substantially equivalent to K073001 (Power Medical Interventions, Inc., 2007) and 3 other predicates after a 57-day review. Its family tree reaches back 9 generations to 1997. 9 later devices descend from it.
- Decided
- Oct 13, 2010
- Review
- 57 days
- Class
- Class II
- Product code
- GDW
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K970720 (1997). 35 ancestors in all, the oldest K801589 (1980). 9 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- 5 generations between
- 3 generations backK052415 Power Linear Cutter Reusable Digital Loading Units with ReloadsPower Medical Interventions, Inc. · 2005 · Recalled
- 2 generations backK063746 Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc. · 2007
- 1 generation backK073001 Idrives, Idrivec, IdrivefPower Medical Interventions, Inc. · 2007 · Recalled
- This deviceK102325 Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca · 2010
- Descendant · cites it directly · 8 of its ownK121510 Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012
- Descendant · 2 generations on · 5 of its ownK160176 Signia StaplerCovidien · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK202864 Tri-Staple 2.0 ReloadsCovidien · 2020
- Descendant · 4 generations on · 0 of its ownK253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™…Covidien (Part of Medtronic) · 2026
- Descendant · 3 generations on · 0 of its ownK201672 Signia Stapler (with new software)Covidien · 2020
Show all 9 generations
- Root · 9 generations backK970720 Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO…Ethicon Endo-Surgery, Inc. · 1997
- 8 generations backK980815 Endopath EZ45 Endoscopic Linear CutterEthicon Endo-Surgery, Inc. · 1998
- 7 generations backK020719 Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM…Power Medical Interventions, Inc. · 2002 · Recalled
- 6 generations backK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
- 5 generations backK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
- 4 generations backK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled
- 3 generations backK052415 Power Linear Cutter Reusable Digital Loading Units with ReloadsPower Medical Interventions, Inc. · 2005 · Recalled
- 2 generations backK063746 Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc. · 2007
- 1 generation backK073001 Idrives, Idrivec, IdrivefPower Medical Interventions, Inc. · 2007 · Recalled
- This deviceK102325 Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca · 2010
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H · 2012 · cites it directly8descendants
- K160176Signia StaplerCovidien · 2016 · 2 generations on5descendants
- K202864Tri-Staple 2.0 ReloadsCovidien · 2020 · 3 generations on1descendant
- K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic) · 2026 · 4 generations on0descendants
- K201672Signia Stapler (with new software)Covidien · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K970720 | Endopath EZ45 Endoscopic Linear Cutter and the Endopath EZ45 NO Knife… | Ethicon Endo-Surgery, Inc. | 1997 | — |
| −8 | K980815 | Endopath EZ45 Endoscopic Linear Cutter | Ethicon Endo-Surgery, Inc. | 1998 | — |
| −7 | K020719 | Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with… | Power Medical Interventions, Inc. | 2002 | 1 |
| −6 | K030653 | Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital… | Power Medical Interventions, Inc. | 2003 | — |
| −5 | K040398 | Surgassist Straight Linear 4 Row NO Knife Dlus with Reloads | Power Medical Interventions, Inc. | 2004 | — |
| −4 | K040720 | Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55… | Power Medical Interventions, Inc. | 2004 | 1 |
| −3 | K052415 | Power Linear Cutter Reusable Digital Loading Units with Reloads | Power Medical Interventions, Inc. | 2005 | 1 |
| −2 | K063746 | Power Extenders Model# PEC200, PES200,PES200S | Power Medical Interventions, Inc. | 2007 | — |
| −1 | K073001 | Idrives, Idrivec, Idrivef | Power Medical Interventions, Inc. | 2007 | 1 |
| 0 (this device) | K102325 | Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload) | Covidien, LLC, Formerly Registered AS Tyco Healthca | 2010 | — |
| +1 | K121510 | Idrive Ultra Powered Handle Endo Gia Adapter | Covidien, Formerly US Surgical A Divison of Tyco H | 2012 | — |
| +2 | K160176 | Signia Stapler | Covidien | 2016 | 14 |
| +3 | K202864 | Tri-Staple 2.0 Reloads | Covidien | 2020 | — |
| +4 | K253657 | Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo… | Covidien (Part of Medtronic) | 2026 | — |
| +3 | K201672 | Signia Stapler (with new software) | Covidien | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 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 GDW? 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 GDW device
- #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 | Decided |
|---|---|---|---|
| * | K073001 | Idrives, Idrivec, IdrivefSummary page 1…Implantable, Staple CLASSIFICATION NAME. Surgical devices - Staple, Implantable PREDICATE DEVICE(S): Covidien, iDriveC (K073001) Covidien, RALC (K012809) Ethicon, CONTOUR Curved… | 2007 |
| * | K012809 | Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Summary page 1…Surgical devices - Staple, Implantable PREDICATE DEVICE(S): Covidien, iDriveC (K073001) Covidien, RALC (K012809) Ethicon, CONTOUR Curved Cutter Stapler (K091 322)… | 2001 |
| * | K091322 | Contour Curved Cutter Stapler and Reloads, Models: CS40B, CS40G, CR40B, CR40GSummary page 1…idien, iDriveC (K073001) Covidien, RALC (K012809) Ethicon, CONTOUR Curved Cutter Stapler (K091 322) Covidien, Autosuture TA DST Series Stapler (KOl1… | 2009 |
| Kept off the family tree | K011386 | FDA’s K011386 is Ebi Osteostim Granules-Resorbable Bone Graft Substitute Our reading of the summary gave K011386, FDA’s number for Ebi Osteostim Granules-Resorbable Bone Graft Substitute (Ebi, L.P.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Covidien, Autosuture TA DST Series Stapler”. Kept off the family tree. | 2001 |
| * | K801589 | Auto Suture Disp. 30, Etc. & Surg. StapSummary page 1…UR Curved Cutter Stapler (K091 322) Covidien, Autosuture TA DST Series Stapler (KOl13860, K801 589) DEVICE DESCRIPTION: Surgical stapler with Powered Handle, delivering implantable… | 1980 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121510 | Idrive Ultra Powered Handle Endo Gia Adapter | 2012 | 8 |
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 13 years and passes through 3 companies; a new generation was cleared every 12 months on median.
- 10 of the 35 ancestors have a recall of any class.
- Of its descendants, K121510 (Covidien, Formerly US Surgical A Divison of Tyco H, 2012) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K073001.
How does its category compare?
All GDW devicesGDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GDW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GDW
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GDW
3in 2025
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · GDW
11,905in 2025
MAUDE reports naming product code GDW, 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 | 8 | 56 | 9 | 2,401 |
| 2008 | 7 | 57 | 0 | 2,380 |
| 2009 | 13 | 27 | 22 | 4,014 |
| 2010 | 10 | 39 | 2 | 3,768 |
| 2011 | 11 | 49 | 9 | 3,826 |
| 2012 | 9 | 45 | 11 (1) | 3,717 |
| 2013 | 13 | 49 | 1 | 3,777 |
| 2014 | 15 | 63 | 0 | 4,784 |
| 2015 | 8 | 111 | 6 | 4,899 |
| 2016 | 11 | 96 | 2 | 5,106 |
| 2017 | 13 | 103 | 3 | 11,643 |
| 2018 | 7 | 90 | 3 | 14,914 |
| 2019 | 12 | 205 | 4 (4) | 16,600 |
| 2020 | 10 | 88 | 11 | 12,332 |
| 2021 | 9 | 233 | 0 | 13,015 |
| 2022 | 7 | 89 | 0 | 13,605 |
| 2023 | 4 | 267 | 1 | 14,623 |
| 2024 | 2 | — | 0 | 13,280 |
| 2025 | 3 | 111 | 3 | 11,905 |
| 2026 | 3 | 141 | 0 | — |
What is it indicated for?
The iDrive™ Powered Handle, when used with the iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.
The iDrive™ Right Angle Linear Cutter (RALC) Single Use Reload, when used with the iDrive™ Powered Handle, is intended for use in gastrointestinal, gynecological, and general abdominal and thoracic surgery for resection, transection of tissues, and creation of anastomoses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102325: Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102325
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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