510(k) Report

510(k) · Cleared

Cleared

HOOK

K841625510(k) TraditionalCleared Aug 27, 1984130-day reviewClass I21 CFR 878.4800

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

Plastafil, Inc. · GAD Retractor

Cleared on Aug 27, 1984 after a 130-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Aug 27, 1984
Review
130 days
Class
Class I
Product code
GAD
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K841625Source: 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 GAD? 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 GAD devices

GAD Retractor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAD

2in 2016

2007: 12013: 12016: 2
2007high 2 (2016) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAD

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

Recalls per year · GAD

1in 2024

2008: 12009: 12013: 32014: 22015: 12022: 12024: 12026 (partial year): 1
2007high 3 (2013) · low 0 (2007)2026

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

Adverse event reports per year · GAD

107in 2025

2007: 382008: 452009: 642010: 522011: 502012: 802013: 882014: 802015: 672016: 782017: 902018: 772019: 622020: 862021: 812022: 802023: 802024: 1112025: 107
2007high 111 (2024) · low 38 (2007)2025

MAUDE reports naming product code GAD, 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
20071—038
20080—145
20090—164
20100—052
20110—050
20120—080
20131—388
20140—280
20150—167
20162—078
20170—090
20180—077
20190—062
20200—086
20210—081
20220—180
20230—080
20240—1111
20250—0107
20260—1—

More from Plastafil, Inc.

13 FDA decisions under this applicant name. See the company

  • K841620Front Radius CutterPlastafil, Inc. · 1984
  • K841621Back Radius CutterPlastafil, Inc. · 1984
  • K841626PUNCHPlastafil, Inc. · 1984
  • K841629Drill BitPlastafil, Inc. · 1984
  • K841617Strover HookPlastafil, Inc. · 1984

Recent decisions in GAD

The GAD category page

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  • K151104Otelo LLSpineart · 2016
  • K132645Thoratrak Mics Retractor System, Rack, BladesMedtronic, Inc. · 2013
  • K071775DASHEzsurgical · 2007
  • K050256Apple Medical/OB Mobius Elastic RetractorApple Medical Corp. · 2005

https://510kreport.com/device/K841625 · printed Nov 4, 2026

Cite this page

510(k) Report. “K841625: HOOK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K841625

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