510(k) Report

510(k) · Cleared

Cleared

Camino Hand Drill - Model 030

K862160510(k) TraditionalCleared Jul 18, 198642-day reviewClass II21 CFR 882.4300

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

Camino Laboratories, Inc. · HBG Drills, Burrs, Trephines & Accessories (Manual)

Cleared on Jul 18, 1986 after a 42-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
Jul 18, 1986
Review
42 days
Class
Class II
Product code
HBG
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK862160 Camino Hand Drill - Model 030Camino Laboratories, Inc. · 1986
  2. Descendant · cites it directly · 1 of its ownK022712 Hand Drill, Model 11-9901-7Medical Design, LLC · 2002
  3. Descendant · 2 generations on · 0 of its ownK032125 Cstat, Models 09-0014-01 and 09-0014-02Vascular Control Systems, Inc. · 2004

Most influential descendants

Showing 2 of 2 · See all
  • K022712Hand Drill, Model 11-9901-7Medical Design, LLC · 2002 · cites it directly1descendant
  • K032125Cstat, Models 09-0014-01 and 09-0014-02Vascular Control Systems, Inc. · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K862160Camino Hand Drill - Model 030Camino Laboratories, Inc.1986—
+1K022712Hand Drill, Model 11-9901-7Medical Design, LLC2002—
+2K032125Cstat, Models 09-0014-01 and 09-0014-02Vascular Control Systems, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
FIG. 1 — Lineage of K862160, 1986–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 HBG? 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 HBG device

  1. #1 K252696 Legacyscore 12.2 · 7 generations · no Class I recall
Get a 510(k) 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)

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

NumberDeviceApplicantDecidedDescendants
K022712Hand Drill, Model 11-9901-7Medical Design, LLC20021

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, K022712 (Medical Design, LLC, 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All HBG devices

HBG Drills, Burrs, Trephines & Accessories (Manual): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HBG

1in 2025

2013: 12015: 12016: 12017: 22025: 1
2007high 2 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HBG

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

Recalls per year · HBG

9in 2023

2009: 12011: 142014: 142023: 92026 (partial year): 1
2007high 14 (2011) · low 0 (2007)2026

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

Adverse event reports per year · HBG

2in 2025

2012: 12013: 12014: 52015: 32017: 62018: 22019: 32021: 12022: 32023: 32024: 112025: 2
2007high 11 (2024) · low 0 (2007)2025

MAUDE reports naming product code HBG, 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—00
20090—10
20100—00
20110—140
20120—01
20131—01
20140—145
20151—03
20161—00
20172—06
20180—02
20190—03
20200—00
20210—01
20220—03
20230—93
20240—011
20251—02
20260—1—

More from Camino Laboratories, Inc.

18 FDA decisions under this applicant name. See the company

  • K932769Camino Ventricular Drainage SystemCamino Laboratories, Inc. · 1995
  • K930221Camino Ventricular Transducer AccessoryCamino Laboratories, Inc. · 1993
  • K930222Camino Ventricular Access DeviceCamino Laboratories, Inc. · 1993
  • K920088Camino Ventricular NeedleCamino Laboratories, Inc. · 1992
  • K914735Ventricular Pressure Monitoring Kit, Model 110-4HMCamino Laboratories, Inc. · 1992

Recent decisions in HBG

The HBG category page

  • K252696LegacyPhasor Health, LLC · 2025
  • K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC · 2017
  • K162884SpineGuard DSG Zavation Screw SystemSpineguard S.A. · 2017
  • K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc. · 2016
  • K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmMri Interventions, Inc. · 2015

https://510kreport.com/device/K862160 · printed Nov 4, 2026

Cite this page

510(k) Report. “K862160: Camino Hand Drill - Model 030.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862160

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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