510(k) Report

510(k) · Cleared

Cleared

Hobbs Medical/Jayco Aspiration Catheter

K844550510(k) TraditionalCleared Jan 3, 198543-day reviewClass II21 CFR 876.1500

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

Hobbs Medical, Inc. · OCX Endoscopic Irrigation/Suction System

Cleared on Jan 3, 1985 after a 43-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jan 3, 1985
Review
43 days
Class
Class II
Product code
OCX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2024: 1 descendant cleared1990200020102020
  1. This deviceK844550 Hobbs Medical/Jayco Aspiration CatheterHobbs Medical, Inc. · 1985
  2. Descendant · cites it directly · 0 of its ownK241874 Aspiration Catheter (2189)Hobbs Medical, Inc. · 2024

Most influential descendants

Showing 1 of 1 · See all
  • K241874Aspiration Catheter (2189)Hobbs Medical, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K844550Hobbs Medical/Jayco Aspiration CatheterHobbs Medical, Inc.1985—
+1K241874Aspiration Catheter (2189)Hobbs Medical, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202410
FIG. 1 — Lineage of K844550, 1985–2024Source: 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.

Planning a device in OCX? 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 OCX device

  1. #1 K251986 Auxiliary Water Tube Maj-855score 12.8 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K241874Aspiration Catheter (2189)Hobbs Medical, Inc.20240

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, K241874 (Hobbs Medical, Inc., 2024) has gone furthest, with 0 descendants of its own.

How does its category compare?

All OCX devices

OCX Endoscopic Irrigation/Suction System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OCX

4in 2025

2009: 12010: 32011: 12012: 42013: 32014: 62015: 22016: 22018: 52019: 82020: 42021: 32022: 62023: 72024: 42025: 4
2007high 8 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OCX

178in 2025

2010: 51 days median2012: 256 days median2013: 106 days median2014: 77 days median2018: 60 days median2019: 133 days median2020: 88 days median2021: 233 days median2022: 84 days median2023: 109 days median2024: 74 days median2025: 178 days median
2007high 256 (2012) · low 51 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OCX

2in 2022

2015: 12020: 112022: 22026 (partial year): 2
2007high 11 (2020) · low 0 (2007)2026

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

Adverse event reports per year · OCX

33in 2025

2008: 12012: 12013: 12014: 52015: 92016: 82017: 92018: 182019: 412020: 112021: 82022: 182023: 462024: 212025: 33
2007high 46 (2023) · low 0 (2007)2025

MAUDE reports naming product code OCX, 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—00
20080—01
20091—00
201035100
20111—00
2012425601
2013310601
201467705
20152—19
20162—08
20170—09
2018560018
20198133041
20204881111
2021323308
2022684218
20237109046
2024474021
20254178033
20260—2—
Cite this page

510(k) Report. “K844550: Hobbs Medical/Jayco Aspiration Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K844550

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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