510(k) · Cleared
ClearedCeleris, Disposable Sinus Debrider
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 Jan 19, 2022 as substantially equivalent to K123429 (Gyrus Acmi, Inc., 2013) and 1 other predicate after a 149-day review. Its family tree reaches back 15 generations to 1994.
- Decided
- Jan 19, 2022
- Review
- 149 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K936109 (1994). 97 ancestors in all, the oldest K780977 (1978). No later device cites it as a predicate yet.
- Root · 15 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 11 generations between
- 3 generations backK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
- 2 generations backK121678 DTADGyrus Acmi, Inc. · 2012
- 1 generation backK123429 Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · Recalled
- This deviceK212650 Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022
Show all 15 generations
- Root · 15 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 14 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 13 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 12 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 11 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 10 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 9 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 8 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 7 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 6 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 5 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 4 generations backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- 3 generations backK083415 Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection DevicePeak Surgical, Inc. · 2009
- 2 generations backK121678 DTADGyrus Acmi, Inc. · 2012
- 1 generation backK123429 Olympus Energy Power System (Eps)Gyrus Acmi, Inc. · 2013 · Recalled
- This deviceK212650 Celeris, Disposable Sinus DebriderGyrus Acmi, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −14 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −13 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −12 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −11 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −10 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −9 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −8 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −7 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −6 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −5 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −4 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| −3 | K083415 | Peak Plasmablade Tna Tonsil and Adenoid Tissue Dissection Device | Peak Surgical, Inc. | 2009 | — |
| −2 | K121678 | DTAD | Gyrus Acmi, Inc. | 2012 | — |
| −1 | K123429 | Olympus Energy Power System (Eps) | Gyrus Acmi, Inc. | 2013 | 12 |
| 0 (this device) | 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 | 5 | 0 |
| 2002 | 6 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K123429 | Olympus Energy Power System (Eps)Summary page 5…Traditional 510(k) Notification Gyrus ACMI, Inc. Predicate Device Gyrus ACMI Inc. Diego® Elite: K123429 Device Description and Technological Characteristics The Gyrus ACMI Disposable Sinus Debrider (DSD) Celeris System is similar i… | 2013 |
| * | K034004 | Diego RF Powered Dissector and Drill System ConsoleSummary page 5…n form and function to the Gyrus ACMI blades and handpieces found within the predicate Diego Elite System cleared under K123429, and its predicate PK Diego cleared under K034004. The Celeris DSD handpiece is a single-use disposable debrider handle and blade permanently combined with a built-in motor that… | 2004 |
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 28 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 9 of the 97 ancestors have a recall of any class.
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. 2022, 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 Celeris System (reusable power pack and Disposable Sinus Debrider) is intended for cutting, coagulation, debriding, and removal of thin bone and soft tissue in general ENT and Sinus/Rhinology procedures. Specific procedures and applications would include:
* FESS (Functional Endoscopic Sinus Surgery) — Including Endoscopic approaches for: Polypectomy, Ethmoidectomy, Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy
* Turbinate Reduction / Turbinoplasty, including sub-mucosal resection.
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/K212650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212650: Celeris, Disposable Sinus Debrider.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212650
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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