510(k) · Cleared
ClearedTarry Medical Temperature Probes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tarry Medical Products, Inc. · FMZ Incubator, Neonatal
Cleared on May 23, 2008 as substantially equivalent to K974349 (Ohmeda Medical, 1998) and 3 other predicates after a 311-day review. Its family tree reaches back 2 generations to 1997. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- May 23, 2008
- Review
- 311 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K950422 (1997). 6 ancestors in all, the oldest K960980 (1996). No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK950422 First Touch Disposables Temperature ProbesFirst Touch Disposables, Inc. · 1997
- 1 generation backK020219 Rpi Skin or Air Temperature ProbeReplacement Parts Industries, Inc. · 2002
- This deviceK071977 Tarry Medical Temperature ProbesTarry Medical Products, Inc. · 2008
Class I recalls in this family
- K974349 Ohmeda-Ohio Care Plus Incubatordirect predicate · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950422 | First Touch Disposables Temperature Probes | First Touch Disposables, Inc. | 1997 | — |
| −1 | K020219 | Rpi Skin or Air Temperature Probe | Replacement Parts Industries, Inc. | 2002 | — |
| 0 (this device) | K071977 | Tarry Medical Temperature Probes | Tarry Medical Products, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 1 |
| 2000 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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 FMZ device
- #1 K251663 Giraffe OmniBed Carestation (CS1); Giraffe…score 14.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K974349 | Ohmeda-Ohio Care Plus IncubatorSummary page 2…R 880.5400 Predicate Device [21 CFR 807.92(a)(3)]: The following devices have been identified as predicate devices: Ohimeda Inc - Ohmeda / Ohio Care Plus Incubators - K974349 Hill-Rom / Air Shields - Isolette Incubators - KOO 1242 / K960980 Replacement Parts Industries - RPI Temperature Probes - K0202… | 1998 |
| * | K001242 | Isolette Infant Incubator, Model C2HS | 2000 |
| * | K960980 | Isolette Infant IncubatorSummary page 2…devices have been identified as predicate devices: Ohimeda Inc - Ohmeda / Ohio Care Plus Incubators - K974349 Hill-Rom / Air Shields - Isolette Incubators - KOO 1242 / K960980 Replacement Parts Industries - RPI Temperature Probes - K020219 Description of the Device [21 CFR 807.92(a)(4)]: The Tarry Med… | 1996 |
| * | K020219 | Rpi Skin or Air Temperature ProbeSummary page 2…Ohmeda / Ohio Care Plus Incubators - K974349 Hill-Rom / Air Shields - Isolette Incubators - KOO 1242 / K960980 Replacement Parts Industries - RPI Temperature Probes - K020219 Description of the Device [21 CFR 807.92(a)(4)]: The Tarry Medical Temperature Probes are intended to be used as replacement pa… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K974349Ohmeda-Ohio Care Plus IncubatorOhmeda Medical · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K974349.
How does its category compare?
All FMZ devicesFMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FMZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMZ
60in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMZ
2in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · FMZ
250in 2025
MAUDE reports naming product code FMZ, 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 | 3 | 81 | 0 | 14 |
| 2008 | 1 | — | 4 | 10 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 4 | 60 | 0 | 11 |
| 2011 | 1 | — | 5 | 10 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 1 (1) | 11 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 1 | — | 1 | 12 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 3 | 18 |
| 2019 | 2 | — | 1 | 24 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 0 | — | 8 (8) | 19 |
| 2024 | 0 | — | 2 (2) | 118 |
| 2025 | 2 | — | 0 | 250 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
The Tarry Medical Temperature Probes are designed to be used as replacement temperature sensing probes for use with infant radiant warmers and infant incubators. The probes provide skin or air temperature feedback in order to maintain pre-selected temperature settings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071977: Tarry Medical Temperature Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071977
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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