510(k) · Cleared
ClearedPMT-Halo/Orthopedic Jacket System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Progress Mankind Technology · HAX Tong, Skull For Traction
Cleared on Feb 17, 1984 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Feb 17, 1984
- Review
- 86 days
- Class
- Class II
- Product code
- HAX
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK834047 PMT-Halo/Orthopedic Jacket SystemProgress Mankind Technology · 1984
- Descendant · cites it directly · 0 of its ownK090733 PMT Halo SystemPmt Corp. · 2009
- Descendant · cites it directly · 0 of its ownK980689 Friddle Halo System, Friddle Mri Halo SystemFriddle'S Orthopedic Appliances, Inc. · 1999
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K834047 | PMT-Halo/Orthopedic Jacket System | Progress Mankind Technology | 1984 | — |
| +1 | K090733 | PMT Halo System | Pmt Corp. | 2009 | — |
| +1 | K980689 | Friddle Halo System, Friddle Mri Halo System | Friddle'S Orthopedic Appliances, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2009 | 1 | 0 |
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 HAX? 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
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? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K090733 (Pmt Corp., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HAX devicesHAX Tong, Skull For Traction: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAX
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · HAX
Too few HAX 510(k)s in any year since 2007 to give a median.
Recalls per year · HAX
4in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HAX
1in 2020
MAUDE reports naming product code HAX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 3 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 6 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 4 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K834047 · printed Nov 6, 2026
Cite this page
510(k) Report. “K834047: PMT-Halo/Orthopedic Jacket System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K834047
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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