510(k) · Cleared
ClearedDTAD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyrus Acmi, Inc. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Aug 30, 2012 as substantially equivalent to K034004 (Gyrus Ent LLC, 2004) and 3 other predicates after an 84-day review. Its family tree reaches back 13 generations to 1994. 2 later devices descend from it.
- Decided
- Aug 30, 2012
- Review
- 84 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K936109 (1994). 93 ancestors in all, the oldest K780977 (1978). 2 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 9 generations between
- 3 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 2 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 1 generation backK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
- This deviceK121678 DTADGyrus Acmi, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK123429 Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 0 of its ownK212650 Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022
Show all 13 generations
- Root · 13 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 12 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 11 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 10 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 9 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 8 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 7 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 6 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 5 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 4 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 3 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 2 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 1 generation backK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
- This deviceK121678 DTADGyrus Acmi, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −12 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −11 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −10 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −9 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −8 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −7 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −6 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −5 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −4 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −3 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −2 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| −1 | K083415 | Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device | Peak Surgical, Inc. | 2009 | — |
| 0 (this device) | K121678 | DTAD | Gyrus Acmi, Inc. | 2012 | — |
| +1 | K123429 | Olympus Energy Power System (Eps) | Gyrus Acmi, Inc. | 2013 | 12 |
| +2 | K212650 | Celeris, Disposable Sinus Debrider | Gyrus Acmi, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 2 | 0 |
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 9 | 0 |
| 1996 | 10 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 1 | 0 |
| 2000 | 12 | 0 |
| 2001 | 4 | 0 |
| 2002 | 6 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2022 | 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 ERL? 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 ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K034004 | Diego RF Powered Dissector and Drill System ConsoleSummary page 2…device and accessories Predicate Devices Gymus ACMI Inc. Diego® RE Powered Dissector & Drill System: K034004 Covidien / ValleyLab Suction Coagulator: K09 1223 Bovie SEER:… | 2004 |
| * | K091223 | Valleylab Suction Coagulator, Model E3305Summary page 2…mus ACMI Inc. Diego® RE Powered Dissector & Drill System: K034004 Covidien / ValleyLab Suction Coagulator: K09 1223 Bovie SEER: K082568 Peak TnA Plasmablade:… | 2009 |
| * | K082568 | Saline Enhanced Electrosurgical Resection (Seer) DeviceSummary page 2…idien / ValleyLab Suction Coagulator: K09 1223 Bovie SEER: K082568 Peak TnA Plasmablade: KO083415 Device Description and Technological… | 2008 |
| * | K083415 | Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DeviceSummary page 2…e SEER: K082568 Peak TnA Plasmablade: KO083415 Device Description and Technological Characteristics The DTAD (Disposable Tonsil and Adenoid Device) is a disposable microdebri… | 2009 |
| † | K041285 | Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123429 | Olympus Energy Power System (Eps) | 2013 | 1 |
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 7 companies; a new generation was cleared every 1.1 years on median.
- 8 of the 93 ancestors have a recall of any class.
- Of its descendants, K123429 (Gyrus Acmi, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K034004.
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, 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 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The DTAD is intended for cutting, coagulation, and removal of tissue in general ENT procedures.
Specific indications include: Tonsillectomy and Adenoidectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121678: DTAD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121678
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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