510(k) Report

510(k) · Cleared

Cleared

Mass (Micro-Access Spine System)

K992583510(k) TraditionalCleared Oct 29, 199988-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

Omni-Tract Surgical, Div. Minn. Scientific, Inc. · HRX Arthroscope

Cleared on Oct 29, 1999 as substantially equivalent to K842762 (Minnesota Scientific, Inc., 1984) and 2 other predicates after an 88-day review. Its family tree reaches back 1 generation to 1984.

Decided
Oct 29, 1999
Review
88 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K842762 (1984). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1987: 1 other ancestor1985: 1 other ancestorK842762 · Omni-Tract Surgical Retractor Sys · Minnesota Scientific, Inc. · 198419801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors K842762 · Omni-Tract Surgical Retractor Sys · Minnesota Scientific, Inc. · 19840
  1. Root · 1 generation backK842762 Omni-Tract Surgical Retractor SysMinnesota Scientific, Inc. · 1984
  2. This deviceK992583 Mass (Micro-Access Spine System)Omni-Tract Surgical, Div. Minn. Scientific, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K842762Omni-Tract Surgical Retractor SysMinnesota Scientific, Inc.1984—
0 (this device)K992583Mass (Micro-Access Spine System)Omni-Tract Surgical, Div. Minn. Scientific, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198710
FIG. 1 — Lineage of K992583, 1984–1999Source: 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
*K842762Omni-Tract Surgical Retractor Sys
Summary page 1
…(21 CFR 888.4540) Common Name: Surgical Retractor System Trade/Proprietary Name: MASS (Micro-Access Spine System) Substahtially OMNI-TRACT Surgical Retractor Systems (K842762, K853947 and Equivalent Products Description: Intended Use: Comparison K872919) and other commercially distributed devices.…
Minnesota Scientific, Inc.1984—
*K853947Omni-Tract Chest Wall & Luna Retractor
Summary page 1
…888.4540) Common Name: Surgical Retractor System Trade/Proprietary Name: MASS (Micro-Access Spine System) Substahtially OMNI-TRACT Surgical Retractor Systems (K842762, K853947 and Equivalent Products Description: Intended Use: Comparison K872919) and other commercially distributed devices. The devi…
Minnesota Scientific, Inc.1985—
*K872919Omni-Tract Corral Retractor
Summary page 1
…ASS (Micro-Access Spine System) Substahtially OMNI-TRACT Surgical Retractor Systems (K842762, K853947 and Equivalent Products Description: Intended Use: Comparison K872919) and other commercially distributed devices. The device a manually adjusted retractor system. It has a single- piece retractor/a…
Minnesota Scientific, Inc.1987—

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?

  • None of the 3 ancestors has a recall.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 intended use is for spinal surgery that is consistent with the working dimensions of the retractor/access port.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Omni-Tract Surgical, Div. Minn.…

4 FDA decisions under this applicant name. See the company

  • K001339Mri Fastsystem Retractor SystemOmni-Tract Surgical, Div. Minn. Scientific, Inc. · 2000
  • K950214Abdominal Wall RetractorOmni-Tract Surgical, Div. Minn. Scientific, Inc. · 1995
  • K913803Intraluminal Artery StripperOmni-Tract Surgical, Div. Minn. Scientific, Inc. · 1992

Recent decisions in HRX

The HRX category page

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  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
  • K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KG · 2026
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https://510kreport.com/device/K992583 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992583: Mass (Micro-Access Spine System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992583

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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