510(k) · Cleared
ClearedDigicap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Humana USA, Inc. · GAB Needle, Suturing, Disposable
Cleared on Dec 19, 2001 as substantially equivalent to K003063 (Gimbel Glove Co., LLC, 2000) and 1 other predicate after a 159-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Dec 19, 2001
- Review
- 159 days
- Class
- Class I
- Product code
- GAB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992539 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K042534Marina Medical Finger ProtectorsMarina Medical Instruments, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992539 | Percuguard | Digit-Pro | 2000 | — |
| 0 (this device) | K012199 | Digicap | Humana USA, Inc. | 2001 | — |
| +1 | K042534 | Marina Medical Finger Protectors | Marina Medical Instruments, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 GAB? 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
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 |
|---|---|---|---|
| * | K003063 | Gimbel Puncture Resistant Latex Surgical Glove with Puncture Resistance Fingertip…Summary page 1…s equivalent to the many surgeon's gloves cleared under the 510(k) process and is most similar to the "Gimbel Puncture Resistant Powder Free Surgical Glove cleared under K003063. It is also similar to the Percuguard cleared under K992539 but differs from it in that the Percuguard is intended for use with a… | 2000 |
| * | K992539 | PercuguardSummary page 1…510(k) process and is most similar to the "Gimbel Puncture Resistant Powder Free Surgical Glove cleared under K003063. It is also similar to the Percuguard cleared under K992539 but differs from it in that the Percuguard is intended for use with an examination glove during injection and examination activit… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042534 | Marina Medical Finger Protectors | 2005 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K042534 (Marina Medical Instruments, Inc., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GAB devicesGAB Needle, Suturing, Disposable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAB
FDA has decided no GAB device since 2007.
Median 510(k) review, days · GAB
Too few GAB 510(k)s in any year since 2007 to give a median.
Recalls per year · GAB
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAB
38in 2025
MAUDE reports naming product code GAB, 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 | 19 |
| 2008 | 0 | — | 0 | 29 |
| 2009 | 0 | — | 0 | 19 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 0 | — | 1 | 8 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 12 |
| 2016 | 0 | — | 0 | 24 |
| 2017 | 0 | — | 0 | 44 |
| 2018 | 0 | — | 0 | 59 |
| 2019 | 0 | — | 0 | 30 |
| 2020 | 0 | — | 0 | 26 |
| 2021 | 0 | — | 0 | 17 |
| 2022 | 0 | — | 0 | 17 |
| 2023 | 0 | — | 0 | 32 |
| 2024 | 0 | — | 0 | 26 |
| 2025 | 0 | — | 0 | 38 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DigiCap™ is a protective finger guard accessory to the surgeon's glove.
1. Intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. DigiCap™ is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures.
2. Facilitate suture handling and placement.
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/K012199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012199: Digicap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012199
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026