510(k) Report

510(k) · Cleared

Cleared

Hall Irrigation System

K852143510(k) TraditionalCleared Jun 26, 198541-day reviewClass I21 CFR 878.4200

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

Hall Surgical, Division of Zimmer, Inc. · GBX Catheter, Irrigation

Cleared on Jun 26, 1985 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 485 devices in its family, counting itself, has a Class I recall. 484 later devices descend from it.

Decided
Jun 26, 1985
Review
41 days
Class
Class I
Product code
GBX
Recalls
None
Predicates
0

484 later devices descend from it, 3 citing it directly. 1 of the 485 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1998: 1 descendant cleared2003: 1 descendant cleared2007: 3 descendants cleared2018: 20 descendants cleared1999: 1 descendant cleared2001: 5 descendants cleared2009: 2 descendants cleared2006: 3 descendants cleared2010: 3 descendants cleared2008: 2 descendants cleared2002: 1 descendant cleared2017: 16 descendants cleared2013: 6 descendants cleared2021: 45 descendants cleared, 1 with a Class I recall12015: 8 descendants cleared2012: 2 descendants cleared2011: 1 descendant cleared2024: 64 descendants cleared2014: 4 descendants cleared2016: 11 descendants cleared2019: 27 descendants cleared2026: 56 descendants cleared2020: 24 descendants cleared2023: 64 descendants cleared2022: 47 descendants cleared2025: 67 descendants cleared1990200020102020
  1. This deviceK852143 Hall Irrigation SystemHall Surgical, Division of Zimmer, Inc. · 1985
  2. Descendant · cites it directly · 478 of its ownK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
  3. Descendant · 2 generations on · 477 of its ownK990524 E9000 SystemLinvatec Corp. · 1999
  4. Descendant · 3 generations on · 447 of its ownK012453 Sodem High Speed System (Electric) (General Orthopedics & Plastic…Sodemsystems · 2001
  5. Descendant · 3 generations on · 447 of its ownK012457 Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001
  6. Descendant · 3 generations on · 446 of its ownK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001

Showing 5 of 484 descendants. See all descendants

Descendants cleared per year

1998: 11999: 12001: 52002: 12003: 12006: 32007: 32008: 22009: 22010: 32011: 12012: 22013: 62014: 42015: 82016: 112017: 162018: 202019: 272020: 242021: 452022: 472023: 642024: 642025: 672026: 56
1998high 67 (2025) · low 0 (2000)2026

Class I recalls in this family

  • K211616 ExcelsiusHub10 generations on · 2021

Most influential descendants

Showing 5 of 484 · See all
  • K981637Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998 · cites it directly478descendants
  • K990524E9000 SystemLinvatec Corp. · 1999 · 2 generations on477descendants
  • K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems · 2001 · 3 generations on447descendants
  • K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001 · 3 generations on447descendants
  • K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001 · 3 generations on446descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K852143Hall Irrigation SystemHall Surgical, Division of Zimmer, Inc.1985—
+1K981637Integrated Drive/Pump System for OtolaryngologyLinvatec Corp.1998—
+2K990524E9000 SystemLinvatec Corp.1999—
+3K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems2001—
+3K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems2001—
+3K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
199910
200150
200210
200310
200630
200730
200820
200920
201030
201110
201220
201360
201440
201580
2016110
2017160
2018200
2019270
2020240
2021451
2022470
2023640
2024640
2025670
2026560
FIG. 1 — Lineage of K852143, 1985–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (484)

See all 484

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981637Integrated Drive/Pump System for OtolaryngologyLinvatec Corp.1998478
K030576Anspach Irrigation Pump and Irrigation Pump IIThe Anspach Effort, Inc.20032
K063326Conmed Linvatec 24K Irrigation SystemConmed Linvatec20071

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 10 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K981637 (Linvatec Corp., 1998) has gone furthest, with 478 descendants of its own.

How does its category compare?

All GBX devices

GBX Catheter, Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GBX

1in 2014

2008: 12014: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GBX

Too few GBX 510(k)s in any year since 2007 to give a median.

Recalls per year · GBX

6in 2025

2010: 12017: 12021: 12022: 292025: 6
2007high 29 (2022) · low 0 (2007)2026

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

Adverse event reports per year · GBX

1,179in 2025

2007: 112008: 162009: 242010: 352011: 412012: 462013: 492014: 512015: 582016: 862017: 1762018: 2772019: 1962020: 1982021: 3832022: 4772023: 6282024: 9452025: 1,179
2007high 1,179 (2025) · low 11 (2007)2025

MAUDE reports naming product code GBX, 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
20070—011
20081—016
20090—024
20100—135
20110—041
20120—046
20130—049
20141—051
20150—058
20160—086
20170—1176
20180—0277
20190—0196
20200—0198
20210—1383
20220—29477
20230—0628
20240—0945
20250—61,179
20260—0—

More from Hall Surgical, Division of Zimmer, Inc.

8 FDA decisions under this applicant name. See the company

  • K942660Hall Microchoice Electric Powered SystemHall Surgical, Division of Zimmer, Inc. · 19941 recall
  • K864734Hall Oral Implant SystemHall Surgical, Division of Zimmer, Inc. · 1987
  • K864929Hall (R) Micro E Powered Surgical Instrument SystHall Surgical, Division of Zimmer, Inc. · 1987
  • K864163Hall Dunbar Drill Guide SystemHall Surgical, Division of Zimmer, Inc. · 1986
  • K862778Hall Cannlula SystemHall Surgical, Division of Zimmer, Inc. · 1986

Recent decisions in GBX

The GBX category page

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  • K052286Deutsch Anti-Blockage Wound DrainThe Catheter Exchange, Inc. · 2005
  • K043515GraftsaverVescare, Inc. · 2005
  • K013417Misonix Irrigation System Moedl BC20PMisonix, Inc. · 2002

https://510kreport.com/device/K852143 · printed Nov 6, 2026

Cite this page

510(k) Report. “K852143: Hall Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K852143

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026