510(k) · Cleared
ClearedIndiscal Digital Manometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baylis Medical Co., Inc. · FMF Syringe, Piston
Cleared on Feb 23, 2011 as substantially equivalent to K020333 (Atrion Medical Products, Inc., 2002) and 1 other predicate after a 203-day review. Its family tree reaches back 4 generations to 1996.
- Decided
- Feb 23, 2011
- Review
- 203 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953522 (1996). 9 ancestors in all, the oldest K904954 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK953522 Usci Ideal Ptca KitRyder Intl. Corp. · 1996
- 3 generations backK962611 Bard Eagle Inflation DeviceRyder Intl. Corp. · 1996
- 2 generations backK972964 Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997
- 1 generation backK020333 Atrion Medical QL Fluid Dispensing SyringeAtrion Medical Products, Inc. · 2002
- This deviceK102192 Indiscal Digital ManometerBaylis Medical Co., Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953522 | Usci Ideal Ptca Kit | Ryder Intl. Corp. | 1996 | — |
| −3 | K962611 | Bard Eagle Inflation Device | Ryder Intl. Corp. | 1996 | — |
| −2 | K972964 | Atrion Medical Balloon Catheter Inflation Device | Atrion Medical Products, Inc. | 1997 | — |
| −1 | K020333 | Atrion Medical QL Fluid Dispensing Syringe | Atrion Medical Products, Inc. | 2002 | — |
| 0 (this device) | K102192 | Indiscal Digital Manometer | Baylis Medical Co., Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 2004 | 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.
Planning a device in FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K020333 | Atrion Medical QL Fluid Dispensing SyringeSummary page 1…ice name Manufactured by 5 10(k) number Atnion Medical QLTM Fluid Anrion Medical Products K020333 Dispensing Syringe Inc. Integra Accurneter Integra I'm Pain… | 2002 |
| * | K033739 | Physician Industries' Durameter SyringeSummary page 1…nrion Medical Products K020333 Dispensing Syringe Inc. Integra Accurneter Integra I'm Pain K033739 ___________________________Management ________ Device IDescription The InDiscalTM D… | 2004 |
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K020333.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The InDiscaTM1 Digital Manometer is indicated to be used for dispensing fluids into the intervertebral disc and monitoring the pressure of those fluids during discography procedures in symptomatic patients with suspected intervertebral disc pathology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102192: Indiscal Digital Manometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102192
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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