510(k) Report

510(k) · Cleared

Cleared

Surgical Head Support

K822169510(k) TraditionalCleared Aug 20, 198228-day reviewClass I21 CFR 882.4440

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

Kelleher Corp. · HBM Headrest, Neurosurgical

Cleared on Aug 20, 1982 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 20, 1982
Review
28 days
Class
Class I
Product code
HBM
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K822169Source: FDA 510(k) database · 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.

Planning a device in HBM? 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
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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?

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.

How does its category compare?

All HBM devices

HBM Headrest, Neurosurgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBM

FDA has decided no HBM device since 2007.

Median 510(k) review, days · HBM

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

Recalls per year · HBM

2in 2023

2023: 2
2007high 2 (2023) · low 0 (2007)2026

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

Adverse event reports per year · HBM

5in 2025

2007: 12008: 12009: 22010: 22011: 22012: 22015: 12016: 22017: 22018: 22019: 102020: 172021: 102022: 52023: 82024: 52025: 5
2007high 17 (2020) · low 0 (2013)2025

MAUDE reports naming product code HBM, 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—01
20080—01
20090—02
20100—02
20110—02
20120—02
20130—00
20140—00
20150—01
20160—02
20170—02
20180—02
20190—010
20200—017
20210—010
20220—05
20230—28
20240—05
20250—05
20260—0—

More from Kelleher Corp.

94 FDA decisions under this applicant name. See the company

  • K822618Emergency Tracheostomy Instrument SetKelleher Corp. · 1983
  • K822268Nagashima NS-Iii ElectronystagmographKelleher Corp. · 1983
  • K823083Electrosurgical UnitKelleher Corp. · 1982
  • K823111Nystymograph AccessKelleher Corp. · 1982
  • K822252Ent Treatment UnitsKelleher Corp. · 1982

Recent decisions in HBM

The HBM category page

  • K911918Swivel Horseshoe HeadrestCodman & Shurtleff, Inc. · 1991
  • K911917Codman Pediatric Horseshoe HeadrestCodman & Shurtleff, Inc. · 1991

https://510kreport.com/device/K822169 · printed Nov 6, 2026

Cite this page

510(k) Report. “K822169: Surgical Head Support.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K822169

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