510(k) Report

510(k) · Cleared

Cleared

Surgical Probe

K890227510(k) TraditionalCleared Jan 27, 19899-day reviewClass I21 CFR 888.4540

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

Kinetic Medical Products · HXB Probe

Cleared on Jan 27, 1989 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 27, 1989
Review
9 days
Class
Class I
Product code
HXB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K890227Source: 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 HXB? 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 HXB devices

HXB Probe: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HXB

FDA has decided no HXB device since 2007.

Median 510(k) review, days · HXB

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

Recalls per year · HXB

1in 2024

2013: 12014: 12024: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · HXB

37in 2025

2008: 12009: 72010: 102011: 102012: 22013: 132014: 112015: 332016: 442017: 582018: 632019: 692020: 392021: 352022: 412023: 472024: 362025: 37
2007high 69 (2019) · low 0 (2007)2025

MAUDE reports naming product code HXB, 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
20090—07
20100—010
20110—010
20120—02
20130—113
20140—111
20150—033
20160—044
20170—058
20180—063
20190—069
20200—039
20210—035
20220—041
20230—047
20240—136
20250—037
20260—0—

More from Kinetic Medical Products

63 FDA decisions under this applicant name. See the company

  • K890385Midwifery/Obstetrical ForcepsKinetic Medical Products · 1989
  • K890387Malleable Placenta CuretteKinetic Medical Products · 1989
  • K890376Vaginal SpeculumKinetic Medical Products · 1989
  • K890382Compression ForcepsKinetic Medical Products · 1989
  • K890380Cervical Biopsy ForcepsKinetic Medical Products · 1989

Recent decisions in HXB

The HXB category page

  • K960539Diao Hand Surgery SetKinetikos Medical, Inc. · 1996
  • K943472Cohort Avb Retractor SystemCohort Medical Products Group, Inc. · 1994
  • K912843Flexmedics Retract Orth Probe, Pettine Bone ProbeFlexmedics · 1991
  • K873652Hook Probe #TM-1376Arthropedics, Inc. · 1987
  • K873651Blunt Measuring Probe W/2MM Gradations #TM-1375Arthropedics, Inc. · 1987

https://510kreport.com/device/K890227 · printed Nov 4, 2026

Cite this page

510(k) Report. “K890227: Surgical Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K890227

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