510(k) · Cleared
ClearedFrios Microsaw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Friadent GmbH · KMW Handpiece, Rotary Bone Cutting
Cleared on Feb 18, 2000 as substantially equivalent to K971692 (Osteomed Corp., 1997) after a 59-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 18, 2000
- Review
- 59 days
- Class
- Class II
- Product code
- KMW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971692 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971692 Osteopower System and AccessoriesOsteomed Corp. · 1997 · Recalled
- This deviceK994298 Frios MicrosawFriadent GmbH · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971692 | Osteopower System and Accessories | Osteomed Corp. | 1997 | 1 |
| 0 (this device) | K994298 | Frios Microsaw | Friadent GmbH | 2000 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KMW? 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 KMW device
- #1 K211584 Oral Surgery Contrascore 2.8 · 4 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971692 | Osteopower System and AccessoriesSummary page 1…ing Instruments and Accessories 21 CFR 872.4120 14.3 IDENTIFICATION OF PREDICATE DEVICES Company Device 510(k) No. | Date Cleared OsteoMed Corp. OsteoPower System and K971692 06/27/97 Accessories 14.4 DEVICE DESCRIPTION The FRIOS MicroSaw is a series of instruments used in preparing bone in dental an… | 1997 |
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.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All KMW devicesKMW Handpiece, Rotary Bone Cutting: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KMW
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · KMW
Too few KMW 510(k)s in any year since 2007 to give a median.
Recalls per year · KMW
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KMW
22in 2025
MAUDE reports naming product code KMW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 27 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 0 | — | 8 | 16 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 1 | — | 1 | 32 |
| 2022 | 0 | — | 0 | 54 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 0 | — | 0 | 49 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The FRIOS MicroSaw is intended for use in preparing bone in conjunction with dental and craniofacial surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994298 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994298: Frios Microsaw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994298
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026