510(k) Report

510(k) · Cleared

Cleared

Asap Muitiscope

K121261510(k) TraditionalCleared Jan 8, 2013257-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

Asap Endoscopic Products GmbH · HRX Arthroscope

Cleared on Jan 8, 2013 as substantially equivalent to K051827 (Joimax GmbH, 2005) and 2 other predicates after a 257-day review. Its family tree reaches back 5 generations to 1999.

Decided
Jan 8, 2013
Review
257 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
3

Its longest line of descent runs back 5 generations to K991794 (1999). 13 ancestors in all, the oldest K941967 (1994). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor1998: 1 other ancestor1994: 2 other ancestors2002: 1 other ancestor2000: 3 other ancestorsK991794 · Endoscopic Spinal Access System · Endius, Inc. · 1999K021748 · Endius Atavi System · Endius, Inc. · 2002K053267 · Endius Atavi System · Endius, Inc. · 2006 · recalledK061246 · Endoscopic Spine System · Arthro Kinetics, Inc. · 2006K083552 · Maxmorespine Tom Stick · Hoogland Spine Products, GmbH · 2009199019952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor K083552 · Maxmorespine Tom Stick · Hoogland Spine Products, GmbH · 2009K061246 · Endoscopic Spine System · Arthro Kinetics, Inc. · 2006K053267 · Endius Atavi System · Endius, Inc. · 2006 · recalledK021748 · Endius Atavi System · Endius, Inc. · 2002K991794 · Endoscopic Spinal Access System · Endius, Inc. · 1999−50
  1. Root · 5 generations backK991794 Endoscopic Spinal Access SystemEndius, Inc. · 1999
  2. 4 generations backK021748 Endius Atavi SystemEndius, Inc. · 2002
  3. 3 generations backK053267 Endius Atavi SystemEndius, Inc. · 2006 · Recalled
  4. 2 generations backK061246 Endoscopic Spine SystemArthro Kinetics, Inc. · 2006
  5. 1 generation backK083552 Maxmorespine Tom StickHoogland Spine Products, GmbH · 2009
  6. This deviceK121261 Asap MuitiscopeAsap Endoscopic Products GmbH · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K991794Endoscopic Spinal Access SystemEndius, Inc.1999—
−4K021748Endius Atavi SystemEndius, Inc.2002—
−3K053267Endius Atavi SystemEndius, Inc.20061
−2K061246Endoscopic Spine SystemArthro Kinetics, Inc.2006—
−1K083552Maxmorespine Tom StickHoogland Spine Products, GmbH2009—
0 (this device)K121261Asap MuitiscopeAsap Endoscopic Products GmbH2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199810
200030
200210
200510
FIG. 1 — Lineage of K121261, 1999–2013Source: 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? (3)

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
*K051827Joimax Endoscope/Multiscope, Thessys Foraminoscope/Multiscope, Thessys…
Summary page 1
…multiscope Common name: Spinal Endoscope Classification Name: Arthroscope and Accessoires (21 CFR 888.1100; Product Code HRX) 5.3 Predicate Devices K051827: Joimax Tessys Multiscope K061246: Arthro Kinetics Endoscopic Spine System K083552: maxMorespine Endoscope 5.4 Desc…
Joimax GmbH2005—
*K061246Endoscopic Spine System
Summary page 1
…ndoscope Classification Name: Arthroscope and Accessoires (21 CFR 888.1100; Product Code HRX) 5.3 Predicate Devices K051827: Joimax Tessys Multiscope K061246: Arthro Kinetics Endoscopic Spine System K083552: maxMorespine Endoscope 5.4 Description of Device The asap mu/tis…
Arthro Kinetics, Inc.2006—
*K083552Maxmorespine Tom Stick
Summary page 1
…essoires (21 CFR 888.1100; Product Code HRX) 5.3 Predicate Devices K051827: Joimax Tessys Multiscope K061246: Arthro Kinetics Endoscopic Spine System K083552: maxMorespine Endoscope 5.4 Description of Device The asap mu/tiscope is a rigid or semiflex-type multi-channel endoscop…
Hoogland Spine Products, GmbH2009—

Also cleared against K051827: 7 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 14 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
  • 1 of the 13 ancestors has a recall of any class.
  • 7 other devices also cite its predicate K051827.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 asap multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy. discectomy, and foraminotomy.

Indications for use as stated in the FDA summary.

Also cleared against K051827

7 other devices cite the same predicate.

  • K141326Needle View CH Scope KitsBiovision Technologies, LLC · 2014
  • K130778Discoscopes, Cervical EndoscopesRz Medizintechnik GmbH · 2014
  • K121482Instrument System for Endoscopic Spinal SurgeryTheken Spine, LLC · 2012
  • K083552Maxmorespine Tom StickHoogland Spine Products, GmbH · 2009
  • K090132Maxmorespine Spinal SystemHoogland Spine Products, GmbH · 2009
  • K082355Visionsense Stereoscopic Vision SystemVisionsense, Ltd. · 2008

More from Asap Endoscopic Products GmbH

5 FDA decisions under this applicant name. See the company

  • K032822Asap Sinuscope…Asap Endoscopic Products GmbH · 2004
  • K031974Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00…Asap Endoscopic Products GmbH · 2003
  • K031972Asap Arthroscope Models; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00…Asap Endoscopic Products GmbH · 2003
  • K031141Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap OesophagoscopeAsap Endoscopic Products GmbH · 2003

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/K121261 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121261: Asap Muitiscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121261

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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