510(k) Report

510(k) · Cleared

Cleared

Indiscal Aspiration Device and Accessories

K092877510(k) TraditionalCleared Nov 17, 200960-day reviewClass II21 CFR 888.1100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Baylis Medical Co., Inc. · HRX Arthroscope

Cleared on Nov 17, 2009 as substantially equivalent to K942987 (Surgical Dynamics, Inc., 1995) and 5 other predicates after a 60-day review. Its family tree reaches back 4 generations to 1992.

Decided
Nov 17, 2009
Review
60 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K922881 (1992). 19 ancestors in all, the oldest K844131 (1984). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 1 other ancestor1994: 1 other ancestor1993: 1 other ancestor1991: 2 other ancestors1990: 1 other ancestor2003: 1 other ancestor2001: 3 other ancestors1984: 1 other ancestor2002: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestorK922881 · Clarus Models 1100, 1101, 1102, 1103 Laser Disc · Clarus Medical Systems, Inc. · 1992 · recalledK022610 · Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160 · Clarus Medical, LLC · 2002×2: 2 generations cleared close together, K040424 (2004), K040919 (2004) 1980198519901995200020052010
Other ancestors, by generation 1 generation back: 5 other ancestors2 generations back: 4 other ancestors3 generations back: 2 other ancestors4 generations back: 4 other ancestors K040919 · Nucleotome Probe Set, Model 21200 · Clarus Medical, LLC · 2004 · recalledK040424 · Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120 · Clarus Medical, LLC · 2004 · recalledK022610 · Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160 · Clarus Medical, LLC · 2002K922881 · Clarus Models 1100, 1101, 1102, 1103 Laser Disc · Clarus Medical Systems, Inc. · 1992 · recalled0
  1. Root · 4 generations backK922881 Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc. · 1992 · Recalled
  2. 3 generations backK022610 Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing…Clarus Medical, LLC · 2002
  3. 2 generations backK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004 · Recalled
  4. 1 generation backK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
  5. This deviceK092877 Indiscal Aspiration Device and AccessoriesBaylis Medical Co., Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K922881Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc.19921
−3K022610Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser…Clarus Medical, LLC2002—
−2K040424Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy…Clarus Medical, LLC20041
−1K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC20041
0 (this device)K092877Indiscal Aspiration Device and AccessoriesBaylis Medical Co., Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
199010
199120
199310
199410
199510
199710
199810
199910
200130
200210
200310
FIG. 1 — Lineage of K092877, 1992–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 HRX? 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 HRX device

  1. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K942987Nucleotome L Kit
Summary page 1
…ate Device Device name Manufactured by 510(k) number Nucleotome Probe (L Kit) Surgical Dynamics K942987 -Nucleotome Probe (E Kit) Surgical Dynamics K931 109 Nucleotome 3.5 mm Automated Surgica…
Surgical Dynamics, Inc.1995—
*K931109Nucleotome E Kit
Summary page 1
…510(k) number Nucleotome Probe (L Kit) Surgical Dynamics K942987 -Nucleotome Probe (E Kit) Surgical Dynamics K931 109 Nucleotome 3.5 mm Automated Surgical Dynamics K923525 Percutaneous Lumbar Probe Nucleotome® II (Versi…
Surgical Dynamics, Inc.1994—
*K923525Nucleotome 3.5 MM Automated Percutaneous Lumbar
Summary page 1
…K942987 -Nucleotome Probe (E Kit) Surgical Dynamics K931 109 Nucleotome 3.5 mm Automated Surgical Dynamics K923525 Percutaneous Lumbar Probe Nucleotome® II (Version2) Tissue Surgical Dynamics K914282 Aspirator/Cutter Sur…
Surgical Dynamics, Inc.1993—
*K914282Nucleotome (R) II (VERSION2) Tissue Aspira/Cutter
Summary page 1
…me 3.5 mm Automated Surgical Dynamics K923525 Percutaneous Lumbar Probe Nucleotome® II (Version2) Tissue Surgical Dynamics K914282 Aspirator/Cutter Surgical Dynamics Nucleotome II Surgical Dynamics K902778 Tissue Aspirator/cutter 21200…
Surgical Dynamics, Inc.1991—
*K902778Surgical Dynamics Nucleotome II Tissue Aspir/Cuter
Summary page 1
…Nucleotome® II (Version2) Tissue Surgical Dynamics K914282 Aspirator/Cutter Surgical Dynamics Nucleotome II Surgical Dynamics K902778 Tissue Aspirator/cutter 21200 Nucleotome Probe Set ISurgical Dynamics K040919 InDi…
Surgical Dynamics, Inc.1990—
*K040919Nucleotome Probe Set, Model 21200
Summary page 1
…al Dynamics Nucleotome II Surgical Dynamics K902778 Tissue Aspirator/cutter 21200 Nucleotome Probe Set ISurgical Dynamics K040919 InDiscal Aspiration Device and Accessories Baylis Medical Company Device Des…
Clarus Medical, LLC20041

Also cleared against K942987: 3 other devices →

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 17 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
  • 4 of the 19 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K942987.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

What is it indicated for?

The InDiscal Aspiration Device and Accessories are intended for aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.

Indications for use as stated in the FDA summary.

Also cleared against K942987

3 other devices cite the same predicate.

  • K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 20041 recall
  • K032473Dekompressor Percutaneous Discectomy ProbeStryker Instruments · 20033 recalls
  • K974464Oratec Spinecath Intradiscal CatheterOratec Interventions, Inc. · 1998

More from Baylis Medical Co., Inc.

28 FDA decisions under this applicant name. See the company

  • K122926Sureflex Steerable Guiding Sheath KitBaylis Medical Co., Inc. · 2013
  • K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc. · 2012
  • K102948Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 20111 Class I recall
  • K102192Indiscal Digital ManometerBaylis Medical Co., Inc. · 2011
  • K101372Duocool Pain Management Probe, Model Osp-17-180-20Baylis Medical Co., Inc. · 2010

Recent decisions in HRX

The HRX category page

  • K263208Vantage Lumbar Decompression KitSurGenTec, LLC · 2026
  • K260156TruVision Single-Use 1.9mm Arthroscopy SystemNexus CMF, LLC · 2026
  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
  • K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG · 2026
  • K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC · 2026

https://510kreport.com/device/K092877 · printed Nov 6, 2026

Cite this page

510(k) Report. “K092877: Indiscal Aspiration Device and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092877

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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