Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Helix Medical, Inc. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
126 daysmedian FDA review time
246 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|
| K023259 | INHEALTH SOFT SLEEVE COLONOSCOPE SPLINT, MODEL CS1200 | Helix Medical, Inc. | 2002-12-26 | 87 | 0 |
| K991587 | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS | Helix Medical, Inc. | 1999-06-25 | 49 | 0 |
| K945287 | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVI | Helix Medical, Inc. | 1994-12-09 | 39 | 0 |
| K945288 | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE | Helix Medical, Inc. | 1994-12-02 | 32 | 0 |
| K932120 | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES | Helix Medical, Inc. | 1994-04-15 | 347 | 2 |
| K932163 | BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET | Helix Medical, Inc. | 1993-12-15 | 225 | 0 |
| K930105 | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. | Helix Medical, Inc. | 1993-05-17 | 126 | 0 |
| K920090 | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET | Helix Medical, Inc. | 1992-09-10 | 246 | 0 |
| K915786 | BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID. | Helix Medical, Inc. | 1992-06-30 | 189 | 0 |
| K904729 | BLOM-SINGER SHOWER GUARD | Helix Medical, Inc. | 1991-02-28 | 134 | 0 |
| K902112 | BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT | Helix Medical, Inc. | 1990-08-01 | 84 | 0 |
| K900518 | BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT | Helix Medical, Inc. | 1990-06-14 | 132 | 0 |
| K897005 | BLOM-SINGER(R) SILICONE LARYNGECTOMY TUBE | Helix Medical, Inc. | 1990-03-16 | 88 | 0 |
| K894220 | HOUTS HYSTERECTOMY DRAIN | Helix Medical, Inc. | 1989-08-24 | 66 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda