510(k) Report

510(k) · Cleared

Cleared

Oscillating Saw/ Reciprocating Saw/ Drill-Reamer

K870157510(k) TraditionalCleared Feb 24, 198742-day reviewClass I21 CFR 878.4820

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

Micro-Aire Surgical Instruments, Inc. · KFK Saw, Pneumatically Powered

Cleared on Feb 24, 1987 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
Feb 24, 1987
Review
42 days
Class
Class I
Product code
KFK
Recalls
None
Predicates
0

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

Descendants, by year cleared 2017: 1 descendant cleared2019: 3 descendants cleared2020: 1 descendant cleared2023: 1 descendant cleared2021: 2 descendants cleared2025: 1 descendant cleared2024: 2 descendants cleared1990200020102020
  1. This deviceK870157 Oscillating Saw/ Reciprocating Saw/ Drill-ReamerMicro-Aire Surgical Instruments, Inc. · 1987
  2. Descendant · cites it directly · 10 of its ownK163182 Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill…Medtronic Powered Surgical Solutions · 2017
  3. Descendant · 2 generations on · 4 of its ownK191597 Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · Recalled
  4. Descendant · 2 generations on · 4 of its ownK183515 MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions · 2019
  5. Descendant · 3 generations on · 3 of its ownK183644 Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019
  6. Descendant · 3 generations on · 2 of its ownK210989 Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module…Brainlab AG · 2021

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2017: 12019: 32020: 12021: 22023: 12024: 22025: 1
2017high 3 (2019) · low 0 (2018)2026

Most influential descendants

Showing 5 of 11 · See all
  • K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating…Medtronic Powered Surgical Solutions · 2017 · cites it directly10descendants
  • K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc. · 2019 · 2 generations on4descendants
  • K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions · 2019 · 2 generations on4descendants
  • K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions · 2019 · 3 generations on3descendants
  • K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic…Brainlab AG · 2021 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K870157Oscillating Saw/ Reciprocating Saw/ Drill-ReamerMicro-Aire Surgical Instruments, Inc.1987—
+1K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System…Medtronic Powered Surgical Solutions2017—
+2K191597Stealth Autoguide System, Midas Rex Legend Depth Stop SystemMedtronic Navigation, Inc.20191
+2K183515MR8 Drill System, Midas Rex MR8 ClearView ToolsMedtronic Powered Surgical Solutions2019—
+3K183644Stealth-Midas MR8 SystemMedtronic Powered Surgical Solutions2019—
+3K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial…Brainlab AG2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201930
202010
202120
202310
202420
202510
FIG. 1 — Lineage of K870157, 1987–2025Source: 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 KFK? 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? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating…Medtronic Powered Surgical Solutions201710

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, K163182 (Medtronic Powered Surgical Solutions, 2017) has gone furthest, with 10 descendants of its own.

How does its category compare?

All KFK devices

KFK Saw, Pneumatically Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KFK

FDA has decided no KFK device since 2007.

Median 510(k) review, days · KFK

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

Recalls per year · KFK

No recall names KFK since 2007.

Adverse event reports per year · KFK

1in 2022

2007: 12010: 12012: 32016: 12018: 12020: 12022: 1
2007high 3 (2012) · low 0 (2008)2025

MAUDE reports naming product code KFK, 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—01
20080—00
20090—00
20100—01
20110—00
20120—03
20130—00
20140—00
20150—00
20160—01
20170—00
20180—01
20190—00
20200—01
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K870157: Oscillating Saw/ Reciprocating Saw/ Drill-Reamer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K870157

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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